Surgical Innovation

$250K awarded to six winners presenting innovative pediatric medical devices

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SZI Symposium Winners

Six companies presenting innovative medical device solutions that address significant unmet needs in pediatric health were awarded a total of $250,000 in grant money yesterday in San Jose, Calif. at the Fifth Annual Pediatric Device Innovation Symposium, organized by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System.

The “Make Your Medical Device Pitch for Kids!” competition is sponsored by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), an FDA-funded consortium led by Children’s National and the A. James Clark School of Engineering at the University of Maryland. Four companies were awarded $50,000 each and two were awarded $25,000. The six winners were selected from a field of twelve finalists. A record 98 total submissions from five countries were received for the competition this year.

“To improve care for children, it is imperative that we recognize and encourage relevant new solutions in pediatric medical devices, especially in light of the challenges innovators face in addressing this specialized market,” said Kurt Newman, M.D., president and CEO of Children’s National. “Children’s National is committed to fostering collaboration among innovators, clinicians, policy makers and investors to advance pediatric device development for the benefit of children everywhere.”

This year’s winning innovations receiving $50,000 awards are:

  • CorInnova, Houston, Texas – soft robotic, non-blood-contacting biventricular cardiac assist device for the treatment of heart failure in children
  • Green Sun Medical, Fort Collins, Colo. – novel device that provides necessary pressure for the correction of spinal deformity while providing real-time feedback to clinicians
  • Hub Hygiene and Georgia Institute of Technology, Atlanta, Ga. – low-cost, single-use cleaning technology to prevent central line-associated blood stream infections (CLABSI), a hospital-acquired infection by pediatric ICU patients
  • NAVi Medical Technologies, Houston, Texas – device to provide accurate information about the localization of an umbilical venous catheter (UVC) used in critically-ill newborns to reduce the risk of catheter malposition

Winning innovations receiving $25,000 awards are:

  • Prapela, LLC, Boston, Mass. – novel “baby box” that will allow for a non-pharmacological approach to help drug-exposed infants relax and sleep during withdrawal and post-withdrawal care
  • X-Biomedical, Inc., Philadelphia, Pa. – portable surgical microscope for use in surgeries for treatable causes of blindness in low-income countries and under-resourced setting

“We are honored to recognize these outstanding innovations with this funding,” said Kolaleh Eskandanian, Ph.D., executive director of the Sheikh Zayed Institute and NCC-PDI. “We are even more excited about welcoming this new cohort of companies to our family of pediatric device startups and entrepreneurs. Together we can move the needle a bit faster and safer to bring pediatric products to market.”

She added that in addition to the financial support and consultation services through NCC-PDI, the awardees can leverage the validation received through this highly competitive process to raise the additional capital needed for commercialization. Since inception in 2013, NCC-PDI has supported 67 pediatric devices and the companies and research labs owning these devices have collectively raised $55 million in additional funding.

The twelve finalists each made five-minute presentations to the symposium audience and then responded to judges’ questions. Finalists also included Anecare, LLC, Salt Lake City, Utah; ApnoSystems, Buenos Aires, Argentina; Deton Corp., Pasadena, Calif.; Kite Medical, Dublin, Ireland; Moyarta 2, LLC, The Plains, Va.; and Oculogica, Inc., New York, N.Y.

Serving on the distinguished panel of judges were Susan Alpert, M.D., of SFA Consulting, a former director of the FDA Office of Device Evaluation and former senior vice president and chief regulatory officer of Medtronic; Charles Berul, M.D., co-director, Children’s National Heart Institute; Andrew Elbardissi, M.D., of Deerfield Management; Rick Greenwald, Ph.D., of the New England Pediatric Device Consortium (NEPDC); James Love, J.D., of Oblon; Josh Makower, M.D., of NEA; Jennifer McCaney, Ph.D., of MedTech Innovator; Jackie Phillips, M.D., of Johnson & Johnson; and Tracy Warren of Astarte Ventures.

The pitch competition is a highlight of the annual symposium organized by the Sheikh Zayed Institute at Children’s National, designed to foster innovation that will advance pediatric healthcare and address the unmet surgical and medical device needs for children. New this year, the symposium co-located in a joint effort with The MedTech Conference powered by AdvaMed, the premier gathering of medtech professionals in North America.

Keynote speakers at the event included Daniel Kraft, M.D., faculty chair of Medicine & Neuroscience, Singularity University and executive director, Exponential Medicine; Vasum Peiris, M.D., chief medical officer, Pediatrics and Special Populations, FDA;  and Alan Flake, M.D., director of Center for Fetal Research, Children’s Hospital of Philadelphia.

Panel discussions focused on gap funding for pediatric innovation, the journey from ideation to commercialization, and the pediatric device needs assessment in the future regulatory environment.

Exchanging ideas

Exchanging ideas, best practices in China

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Exchanging ideas

Physicians from the Children’s National delegation attended the Shanghai Pediatric Innovation Forum in June 2017. Pictured (left to right): Roberta DeBiasi, M.D., Michael Mintz, M.D., Robert Keating, M.D., Lawrence Jung, M.D., Peter Kim, M.D., and Sarah Birch, D.N.P., A.P.R.N.

In late June, a delegation of international pediatric experts from Children’s National Health System journeyed across the world to learn about the practice of pediatric medicine in China and to exchange ideas with colleagues there. Leaders from several of Children’s key specialties joined the delegation, including:

The group, led by Drs. Keating and Gaillard, traveled to China with Children’s Outreach Coordinator John Walsh, whose longtime connections and close familiarity with the pediatric medical community in Hangzhou and Shanghai made the collaboration possible. The team toured several of the largest children’s hospitals in country, including The Children’s Hospital of Zhejiang University School of Medicine in Hangzhou and Shanghai Children’s Medical Center, connecting with pediatric specialists there.

“Some of the most important parts of this trip were the opportunities to exchange ideas and solidify long term relationships that will allow us to work closely with our peers in China as they develop their pediatric programs. The potential is tremendous for unique collaborations between our teams and theirs for research and the development of clinical care improvements for children,” said Roger Packer, M.D., senior vice president of the Center for Neuroscience and Behavioral Health, who joined the delegation in Beijing.

A keynote lecture and more at the 3rd China International Forum on Pediatric Development

The delegation also was honored with an invitation to participate in the 3rd China International Forum on Pediatric Development. The forum is one of the largest pediatric focused meetings in the country and is led by all the major children’s hospitals in China, including those in Beijing and Shanghai. Close to 4,000 pediatricians attended the meeting, and presenters included esteemed international leaders in pediatric medicine from around the world.

Dr. Packer delivered one of the opening keynote lectures, entitled, “Translation of molecular advances into care: the challenge ahead for children’s hospitals.” His talk focused on the tremendous promise and significant challenges posed by the latest scientific advances, through the lens of a neurologist.

“Across the world, we are looking at the same challenges: How can we use scientific advances to find better outcomes? How can we financially support the new types of interventions made possible by these molecular biologics insights when they can cost millions of dollars for one patient?”

“There’s palpable excitement that these new developments will give us potential therapies we never dreamed about before, ways to reverse what we initially thought was irreversible brain damage, ways to prevent severe illnesses including brain tumors, but the issue is how to turn this promise into reality. That’s a worldwide issue, not simply a single country’s issue,” he continued.

He also flagged mental health and behavioral health as a crucial, universal challenge in need of addressing on both sides of the Pacific.

The Children’s National delegation, including Drs. DeBiasi, Song, Keating, Gaillard and Packer were also honored to share their insight in a series of specialty-specific breakout sessions at the Forum.

Overall, the long journey opened a dialogue between Children’s National and pediatric care providers in China, paving the way for future discussion about how to learn from each other and collaborate to enhance all institutions involved.

Oluigbo and Myseros neurosurgery

Working miracles to quiet seizures and preserve brain power in newborns

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Oluigbo and Myseros neurosurgery

In the spring of 2017, a multidisciplinary team applied an innovative approach to help preserve function in the working right hemisphere of a baby who experienced her first seizure hours after birth.

When orderly fetal brain development is disturbed, infants can be born with hemimegalencephaly – a rare occurrence – that results in one of the brain’s two hemispheres being oversized, heavy and malformed. Children with hemimegalencephaly can develop horrible seizures within the first few moments of life. According to published research, every month these infants experience uncontrolled seizures correlates to a steep decline in IQ.

Because these types of seizures do not respond to multiple seizure medications – and anticonvulsant medicines cause worrisome side effects of their own – care teams attempt to schedule surgery as soon as feasible to neutralize the hemisphere triggering the damaging seizures. They either remove it, or they sever nerve fibers and that hemisphere’s blood supply in order to leave it in place.

“The ‘bad’ brain does not sustain any function and it interferes with the ‘good’ brain doing what it needs to do,” says William D. Gaillard, M.D., chief of Children’s National Division of Epilepsy and Neurophysiology and chief of Neurology.

Hemispherectomy is intricate surgery on an organ that is softer than normal and crisscrossed with a tangle of blood vessels that supply the damaged hemisphere with blood. Because of the risks of life-threatening blood loss in very young infants, the dramatic surgery usually does not occur until babies are at least 3 months old and weigh at least 10 pounds.

The challenge: The vulnerable babies who most need relief, infants who have been seizing since delivery, are too young for the operation.

Children’s Pediatric Neurosurgeon Chima Oluigbo, M.D., F.R.C.S.C., had pioneered an innovative approach to clamp off the carotid artery to reduce blood loss during the surgery. Dr. Gaillard says that inspired approach got the team thinking: What if we use embolization – blocking blood supply to targeted locations in the brain – to achieve the same effect?

“It was eye-opening for us to think about actually inflicting brain injury as a way of treating something in the brain that was causing seizures. That is really novel in itself: We’re thinking out of the box in applying existing techniques in a different age group. The conventional thinking with newborns is to let them be; their seizures don’t look that bad,” says Taeun Chang, M.D., director of Children’s Neonatal Neurology and Neonatal Neurocritical Care Program.

“We have evidence to suggest this is a safe and effective way of avoiding recurrent seizures and minimizing the need to give these infants toxic medications so early in life. Ultimately, this helps a select group of  kids who need the surgery to get to the point of being old enough to have it – all the while sparing the healthy part of their brain,” Dr. Gaillard adds.

In the spring of 2017, the multidisciplinary team applied the innovative approach to help preserve function in the working right hemisphere of a baby named Darcy Murphy. Darcy experienced her first seizure hours after she was born, and when she arrived at Children’s National had been in and out of two different emergency rooms in another state for the first few weeks of her life.

Darcy hemimegalencephaly

Once the embolization ended Darcy’s most severe seizures, the little girl could make eye contact, started smiling, and then graduated from smiling to full laughs. In weekly physical therapy, the infant works on tummy time, head control and ensuring her eyes track.

The team explained to the Murphy family that Darcy was on multiple medications but her seizures continued unabated. The options included inducing a coma, sending Darcy home despite ongoing seizures or minimally invasive embolization.

“We would not have even posed this if we were not confident in our ability to do the procedure and deal with potential complications,” Dr. Chang says.

“Oh my gosh, as a parent you know what you’re doing is permanent,” says Rachel Murphy, 29, Darcy’s mom said of the decisions that she and husband Ryan, 33, faced for the youngest of their three children. “What if it’s not the right decision? What if in a week they come out with a new procedure you could have done? We were horrified all the time. The nice part with this procedure is the reward is apparent very quickly, and it just gets better. You don’t have to wait two years to know you made the right decision. You can see half a brain is better than the whole thing for this specific child.”

Once the embolization ended Darcy’s most severe seizures, the little girl could make eye contact, started smiling, and then graduated from smiling to full laughs. In weekly physical therapy, the infant works on tummy time, head control and ensuring her eyes track.

“With hemispherectomy, the kids will lose half of their vision in both eyes. It’s not that they’re blind. Their eyes work fine. When images are sent back to brain to be reflected, there is nothing on the left side reflecting back,” Rachel adds.

Children’s multidisciplinary care team includes experts in newborn intensive care (neonatologists) to aggressively manage seizures in the traditional fashion as they occur and to monitor vital signs; a neonatal neurologist/neurointensivist at the bedside and in the Angio suite monitoring Darcy’s brain activity; a neonatal epileptologist; a surgical epilepsy team; an interventional neuroradiologist from Johns Hopkins; neurosurgeons to perform the delicate functional hemispherectomy; and physical therapists working to help Darcy achieve maximum function after surgery.

“We were just like one unit in the sense of being able to provide coherent, comprehensive care. It’s about blood pressure management, breathing, electrolytes, making sure everything is right for going to the operating room,” Dr. Chang explains. “Darcy’s case highlights the ways in which Children’s National is different and offers personalized care that is superior to other centers.”

The team, which has already published a case report of two previous serial embolizations followed by hemispherectomy, plans follow-up papers describing EEG manifestations during an acute stroke in a newborn, advice to the field on best practices for the embolization and using cooling to minimize brain herniation.

Related resources

Chima Oluigbo

A novel way to treat intractable epilepsy caused by hemimegalencephaly

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Chima Oluigbo

A multidisciplinary team led by Chima Oluigbo, M.D., F.R.C.S.C., pioneered a novel technique to preserve newborns’ healthy brain tissue, buying time until the infants became old enough to undergo a hemispherectomy.

PDF Version

What’s known

Hemimegalencephaly is an extremely rare birth defect in which one side of the brain grows larger than the other. This anomaly typically leads to severe, recurrent seizures that can be difficult to control solely with medications. While the seizures themselves are detrimental to the developing brain, the amount of medications used to reduce seizure frequency often come with significant side effects and have the potential to hamper brain growth. Hemispherectomy, a radical surgery in which one half of the brain is removed, is often the most successful way to treat severe and intractable epilepsy. However, this surgery can be challenging to perform successfully in very young babies.

What’s new

In this case report, the Children’s National Health System Epilepsy Team led by Chima Oluigbo, M.D., F.R.C.S.C., a pediatric neurosurgeon; Tammy N. Tsuchida, M.D., PhD., a pediatric surgical epileptologist; Monica Pearl, M.D., a pediatric interventional neuroradiologist; Taeun Chang, M.D., a neonatal neurointensivist; and the neonatal intensive care team explored the possibility of using minimally invasive surgery to cut off the blood supply to the brain hemisphere responsible for generating seizures in newborns with hemimegalencephaly. This procedure, they reasoned, could buy time for babies to mature and become more resilient to withstand the future hemispherectomy while also lessening the damage caused by uncontrolled, recurrent seizures. The case report focused on the first two patients with hemimegalencephaly who had sequential procedures to gradually restrict blood flow to the affected brain hemisphere within their first few weeks of life, followed by hemispherectomies at a few months of age. This novel approach significantly lessened their seizures until hemispherectomy, allowing these children to continue to grow and develop seizure-free.

Questions for future research

Q: Which patients are best suited for this surgical procedure?
Q: How can surgeons reduce the risk of excessive blood loss during hemispherectomy caused by the growth of additional blood vessels after flow through the brain’s major vessels has been blocked?
Q: What are the long-term outcomes for infants who undergo these procedures?

Source: “ ‘Endovascular embolic hemispherectomy’: A strategy for the initial management of catastrophic holohemispheric epilepsy in the neonate.” Oluigbo, C., M.S. Pearl, T.N. Tsuchida, T. Chang, C.-Y. Ho and W. D. Gaillard. Published by Child’s Nervous System October 29, 2016.
STAR Team

STAR robot is finalist in NASA iTech challenge

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STAR Team

Children’s National Health System’s proprietary robotic surgical technology Smart Tissue Autonomous Robot (STAR) has been named one of the top ten finalists in the 2017 NASA iTech call for ideas challenge.

The Sheikh Zayed Institute for Pediatric Surgical Innovation’s intelligent Smart Tissue Autonomous Robot (STAR) has been named one of the top ten finalists in the 2017 NASA iTech challenge.

The team will present the project at the NASA iTech Forum on July 12-13, 2017 at the National Institute of Aerospace in Hampton, VA, where leaders from NASA and prospective stakeholders will evaluate the 10 finalists and select three top solutions.

“We’re honored to be selected as a finalist in this prestigious challenge,” said Peter C. Kim, M.D., vice president and associate surgeon in chief at Sheikh Zayed Institute at Children’s National. “Our technology is capable of many solutions that would be useful as part of NASAs deep space exploration, including intelligent pods capable of common intelligent autonomous surgical procedures.”

A cutting-edge system, STAR was the first to perform a successful autonomous robotic soft tissue surgery on a live subject in May 2016 and is licensed to Omniboros.

e-learning

Gamifying e-learning for medical education

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e-learning

Computer-based learning simulations and training modules hold the promise to create “virtual patients,” enhancing opportunities for real-time learning and evaluation in medical education.

Today’s e-learning platforms are often static, one-way programs or web pages that ask passive users to read text or watch a video on screen. However, the emerging generation of e-learning features dynamic visualizations and interactions that immerse the user in real-time settings. Military pilots and vehicle operators, for example, still log hours in traditional ways, such as hands-on simulation and flight time, but now also sit in front of a computer and practice tackling unique scenarios designed to challenge and improve their real-time decision making under pressure.

In medical education, computer-based learning simulations and training modules have the promise to create “virtual patients,” giving trainees and physicians the opportunity for real-time evaluation and application of evidence-based care models. Mary Ottolini, M.D., M.P.H., M.Ed., vice chair of medical education and designated institutional official, and Jeff Sestokas, M.Ed., director of the E-Learning Center, are at the forefront of developing these types of training modules for a wide variety of users with variable experience and specialty/sub-specialty expertise in pediatric medicine.

Instructional technologists, multimedia developers and members of the Children’s Academy of Pediatric Educators (CAPE) – some of the nation’s best pediatric clinicians and medical educators – all work collaboratively to design programs that achieve specific educational goals. Each platform resides in a responsive template, making it accessible on a variety of devices and highly customizable to the needs of specific learners. A multitude of online communication and educational tactics are available to enhance learning, including live and archived lectures, forums, blogs, wikis, documents, training modules, virtual simulations, quizzes, podcasts and videoconferencing. Within each platform, individual educators have the ability to customize learning experiences even further, selecting specific modules and specialty content.

“We’re taking these tools to people where they are, and delivering the content in ways that really embrace how this latest generation of trainees receives and processes information,” says Sestokas.

Designed for Children’s National and sites around the country, the majority of the 25 plus platforms and portals created so far focus on what Children’s experts know best – the unique challenges and needs of pediatric patients and their families.

Mary Ottolini

Mary Ottolini, M.D., M.P.H., M.Ed.

For example, clinical scenarios encompass more than simple clinical evaluation and diagnosis. The learning module BEARScalpel teaches surgical residents with limited prior exposure to pediatric care how to address common communication challenges that arise when interacting with pediatric patients and their families. Maybe the “digital” family has a language barrier or a child is in more grave condition than it appears and the trainee has to decide when and how to escalate the issue to an attending physician.

Another module asks participants to diagnose a three-dimensional nonverbal “digital” infant, based on visual and audio cues such as type of cry, skin tone and overall responsiveness.

This type of case-driven learning is relatively new in the universe of electronic medical education, but is showing early promise to improve students’ analytical thinking and problem solving skills.

“There is a lot of medical e-learning available,” Sestokas adds. “But not much e-learning is case-based. That’s something we’re doing that few others do, even in adult-focused medical education.”

A recently published study measured the success of one platform at achieving its educational goals. Participants had higher satisfaction, reported higher impact on knowledge and demonstrated higher scores on metrics assessing behavior change in a virtual environment when compared to the traditional format of reading. The results suggest that interactive modules are not only a preferred method of content delivery but also more likely to improve resident performance. This assessment was made possible by sophisticated tracking systems built into each platform. The data collection provides a steady stream of intelligence about user interaction with presentation format and content, and the material’s contribution to learning goals.

“These systems augment the long standing medical education practices of hands-on simulation and bedside patient care rotations, to allow us to expose trainees and physicians to more scenarios, more complications, and more challenging decisions. We know that the value of a trainee’s education is based on the quality of the cases they are exposed to,” says Dr. Ottolini. “Our goal is to equip these trainees with tools to care for pediatric patients in the future, but to also improve their ability to care for patients today, while they continue to learn.”

As a result of this innovative work, Children’s National is one of seven institutions, and the only children’s hospital, selected to receive an Accreditation Council for Graduate Medical Education (ACGME) Innovation Award that will develop next generation of learning resources for faculty and trainees around the country.

“We have the opportunity to ensure that we are doing the best possible job of training and continuously developing pediatric experts in a field that is rapidly changing and adapting,” concludes Dr. Ottolini. “The best way to do this is to develop flexible training systems that engage users, establish a habit of lifelong learning, and instill a desire for clinical care improvement.”

 


One patient-focused module creates a virtual grocery store to help patients
and families with celiac disease learn how to identify gluten-free food.

test tubes

2016: A banner year for innovation

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test tubes

In 2016, clinicians and research scientists working at Children’s National Health System published more than 1,100 articles in high-impact journals about a wide array of topics. A Children’s Research Institute review group selected the top articles for the calendar year considering, among other factors, work published in top-tier journals with impact factors of 9.5 and higher.

“Conducting world-class research and publishing the results in prestigious journals represents the pinnacle of many research scientists’ careers. I am pleased to see Children’s National staff continue this essential tradition,” says Mark L. Batshaw, M.D., Physician-in-Chief and Chief Academic Officer at Children’s National. “While it was difficult for us to winnow the field of worthy contenders to this select group, these papers not only inform the field broadly, they epitomize the multidisciplinary nature of our research,” Dr. Batshaw adds.

The published papers explain research that includes discoveries made at the genetic and cellular levels, clinical insights and a robotic innovation that promises to revolutionize surgery:

  • Outcomes from supervised autonomous procedures are superior to surgery performed by expert surgeons
  • The Zika virus can cause substantial fetal brain abnormalities in utero, without microcephaly or intracranial calcifications
  • Mortality among injured adolescents was lower among patients treated at pediatric trauma centers, compared with adolescents treated at other trauma center types
  • Hydroxycarbamide can substitute for chronic transfusions to maintain transcranial Doppler flow velocities for high-risk children with sickle cell anemia
  • There is convincing evidence of the efficacy of in vivo genome editing in an authentic animal model of a lethal human metabolic disease
  • Sirt1 is an essential regulator of oligodendrocyte progenitor cell proliferation and oligodendrocyte regeneration after neonatal brain injury

Read the complete list.

Dr. Batshaw’s announcement comes on the eve of Research and Education Week 2017 at Children’s National, a weeklong event that begins April 24. This year’s theme, “Collaboration Leads to Innovation,” underscores the cross-cutting nature of Children’s research that aims to transform pediatric care.

Smart Tissue Autonomous Robot

Robotic system automates soft-tissue surgery

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Smart Tissue Autonomous Robot

STAR’s performance was measurably better in some respects, compared with surgeons performing the same procedure manually or with conventional robotic techniques.

PDF Version

What’s known

Robotic surgery has been increasingly adopted for a variety of procedures. However, conventional robotic surgery is still controlled by individual surgeons. One way to avoid variabilities and improve outcomes is to automate entire procedures or parts of procedures. Thus far, autonomous robotic surgery has been limited to parts of the body with rigid anatomy, because of the unpredictability of soft tissues. These structures can move in unexpected ways during cutting, suturing or cauterizing. No autonomous robotic systems for soft-tissue procedures have been developed due to technology lags, including a lack of vision systems that can distinguish and track tissue in dynamic surgical environments, and intelligent algorithms.

What’s new

A team of researchers led by Peter C.W. Kim, M.D., Ph.D., Vice President, and Axel Krieger, Ph.D., Assistant Professor of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System, developed the Smart Tissue Autonomous Robot (STAR) for performing autonomous soft-tissue surgeries. The researchers tested its capability in three areas: Suturing a cut along a length of suspended intestine, suturing together two pieces of intestine removed from an experimental model and suturing together two pieces of intestine inside a living experimental model. The autonomous robot’s performance was measurably better in some respects, compared with surgeons trained for at least seven years performing the same procedure manually or with conventional robotic techniques. STAR’s stitches were more consistent and less prone to leaks. This demonstration of supervised autonomous surgical tasks by a robot promises that surgeons can improve their technical and decision-making skills in the not-too-distant future, working collaboratively with intelligent robots to improve clinical outcomes.

Questions for future research

Q: Can autonomous robots be used for soft-tissue procedures more complicated than suturing?
Q: Can this system be miniaturized for complex procedures taking place in a confined space, such as suturing together blood vessels?
Q: How can we make more intelligent robots available to all surgeons?

Source: “Supervised autonomous robotic soft tissue surgery.” Shademan A., R.S. Decker, J.D. Opfermann, S. Leonard, A. Krieger and P.C.W. Kim. Published by Science Translational Medicine on May 4, 2016.

Karun Sharma, M.D., poses with two patients

Treating osteoid osteoma with MR-HIFU

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Karun Sharma, M.D., poses with two patients

Karun Sharma, M.D., poses with two patients who participated in the MR-HIFU trial for pediatric osteoid osteoma.

Doctors from the Sheikh Zayed Institute for Pediatric Surgical Innovation and surgeons from Children’s National are the first in the U.S. to use Magnetic Resonance-Guided High-intensity Focused Ultrasound (MR-HIFU) to treat pediatric osteoid osteoma.

The trial, led by Principal Investigator Karun Sharma, M.D., Ph.D., Director of Interventional Radiology at Children’s National, began in 2015 and is demonstrating early success in establishing the safety and feasibility of noninvasive MR-HIFU as an alternative to the current, more invasive approaches to remove tumor tissue.

Osteoid osteoma is a painful, but benign, bone tumor that commonly occurs in children and young adults. Removal generally requires orthopaedic surgery to scrape the tumor from the bone or CT (computerized tomography) image-guided radiofrequency ablation (RFA), which is less invasive than surgery but is associated with ionizing radiation exposure and requires drilling through muscle and soft tissue into bone.

MR-HIFU, on the other hand, is a precise and controlled method that does not require a scalpel or needle, greatly reducing the risk of complications, including infections and bone fractures. Even better, it promises reduced procedure time, typically an hour or less.

“Our team set out to provide a noninvasive and radiation free treatment option for children with osteoid osteoma and our pilot feasibility and safety trial is almost completed. We have treated 9 patients and we’re very pleased with the success of the treatments so far. Although follow up will continue for another year, results to date that show that MR-HIFU may be a completely non-invasive and radiation free treatment for osteoid osteoma,” Dr. Sharma says. “Several of the children we treated were very active prior to the onset of their tumor, one a soccer player and the other a swimmer, but because of pain from the tumor, they were unable to enjoy their favorite activities, until now.”

“The use of MR-HIFU ablation of osteoid osteoma is a perfect example of our mission in the Sheikh Zayed Institute to make pediatric surgery more precise and less invasive,” adds Peter Kim, M.D., C.M., Ph.D., Vice President of the Sheikh Zayed Institute, who leads the Image Guided Non-Invasive Therapeutic Energy (IGNITE) program.

IGNITE is a joint clinical and research collaboration between the Sheikh Zayed Institute and the Divisions of Radiology, Oncology, Surgery, and Anesthesiology at Children’s National. MR-HIFU is also being used to treat pediatric refractory soft tissue tumors, a first-in-the-world clinical trial that is a collaboration between Children’s National and the NIH Center for Interventional Oncology directed by Bradford Wood, MD. Additionally, the IGNITE team has started preliminary work to explore applications of MR-HIFU for noninvasive ablation of growth plates and pediatric solid tumors.

In addition to Drs. Sharma and Kim, the team for the ablation of osteoid osteoma clinical trial includes: AeRang Kim, MD, PhD, pediatric oncologist; Matthew Oetgen, M.D., Division Chief of Orthopaedic Surgery and Sports Medicine; Kaleb Friend, M.D., pediatric orthopedic surgeon; Pavel Yarmolenko, Ph.D., Haydar Celik, Ph.D., and Avinash Eranki, biomedical engineers; Viktoriya Beskin, MR technologist; and Janish Patel, M.D., and Domiciano Santos, M.D., pediatric anesthesiologists.

cord blood

T-cell therapy success for relapsing blood cancer

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cord blood

A unique immunotherapeutic approach that expands the pool of donor-derived lymphocytes (T-cells) that react and target three key tumor-associated antigens (TAA) is demonstrating success at reducing or eliminating acute leukemias and lymphomas when these cancers have relapsed following hematopoietic stem cell transplant (HSCT).

“There’s currently a less than 10 percent chance of survival for a child who relapses leukemia or lymphoma after a bone marrow transplant—in part because these patients are in a fragile medical condition and can’t tolerate additional intense therapy,” says Kirsten Williams, M.D., a blood and marrow transplant specialist in the Division of Hematology at Children’s National Health System, and principal investigator of the Research of Expanded multi-antigen Specifically Oriented Lymphocytes for the treatment of VEry High Risk Hematopoietic Malignancies (RESOLVE) clinical trial.

The unique manufactured donor-derived lymphocytes used in this multi-institutional Phase 1 dose-ranging study are receptive to multiple tumor-associated antigens within the cell, including WT1, PRAME, and Survivin, which have been found to be over-expressed in myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), B-cell AML/MDS, B-cell acute lymphoblastic leukemia (ALL), and Hodgkins lymphoma. Modifying the lymphocytes for several antigens, rather than a single target, broadens the ability of the T-cells to accurately target and eradicate cancerous cells.

Preliminary results demonstrate a 78 percent response rate to treatment, and a 44 percent rate of total remission for participating patients. To date, nine evaluable patients with refractory and relapsed AML/MDS, B-cell ALL, or Hodgkins lymphoma have received 1-3 infusions of the expanded T-cells, and of those, seven have responded to the treatment, showing reduction in cancer cells after infusion with little or no toxicity. All of these patients had relapse of their cancer after hematopoietic cell transplantation. The study continues to recruit eligible patients, with the goal of publishing the full study results within the next 12 months.

“Our preliminary data also shows that this new approach has few if any side effects for the patient, in part because the infused T-cells target antigens that are found only in cancer cells and not found in healthy tissues,” Dr. Williams notes.

The approach used to expand existing donor-derived TAA-lymphocytes, rather than using unselected T cells or genetically modified T-cells as in other trials, also seems to reduce the incidence of post infusion graft versus host disease and other severe inflammatory side effects. Those side effects typically occur when the infused lymphocytes recognize healthy tissues as foreign and reject them or when the immune system reacts to the modified elements of the lymphocytes, she adds.

“These results are exciting because they may present a truly viable option for the 30 to 40 percent of children who will relapse post-transplant,” Dr. Williams concludes. “Many of the patients who participated were given two options: palliative care or this trial. To see significant success and fewer side effects gives us, and families with children facing relapsing leukemia, some hope for this new treatment.”

Dr. Williams discussed the early outcomes of the RESOLVE trial during an oral presentation at the American Society for Blood and Marrow Transplantation meeting on February 22, 2017.

“The early indicators are very promising for this patient population,” says Catherine Bollard, M.D., M.B.Ch.B., Chief of the Division of Allergy and Immunology, Director of the Program for Cell Enhancement and Technologies for Immunotherapy (CETI) at Children’s National, and senior author of the study. “If we can achieve this, and continue to see good responses with few side effects, it’s possible these methods could become a viable alternative to HSCT for patients with no donor match or who aren’t likely to tolerate transplant.”

This is one of the first immunotherapeutic approaches to successfully capitalize on the natural ability of human T-cells to kill cancer, though previous research has shown significant success for this approach in reducing the deadly impact of several viruses, including Epstein-Barr virus, adenovirus, and cytomegalovirus, post HSCT. These new findings have led to the development of additional clinical trials to investigate applications of this method of TAA-lymphocyte manufacture and infusion for pre-HSCT MDS/AML, B-cell ALL, Hodgkins Lymphoma, and even some solid tumors.

MR-guided right heart catheterization live streams at SCMR scientific sessions

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Interventional Cardiac Magnetic Resonance (ICMR) Program Team

The ICMR team who performed the livestream procedure during the member assembly session. The prestigious invitation came as a result of the innovative partnership between Children’s National and the NHLBI to form the Interventional Cardiac MR Program.

Cardiologists from the Interventional Cardiac Magnetic Resonance (ICMR) Program at Children’s successfully live streamed a right heart catheterization procedure guided by magnetic resonance (MR) imaging during the Member Assembly Session of the Society for Cardiac Magnetic Resonance Scientific Session in early February.

The ICMR program is a first-in-the-nation partnership between Children’s National and the National Heart, Lung, and Blood Institute that features a state-of-the-art dedicated cardiac specific MRI suite for diagnosis, evaluation and intervention for children with heart conditions. The program’s goal is to advance diagnostic and interventional cardiac magnetic resonance imaging techniques in pediatric cardiology and for adults with congenital heart disease. ICMR is cross-disciplinary, connecting researchers, clinicians, engineers and physicists to provide more precise and less invasive diagnostics and treatment options that also reduce radiation exposure for vulnerable patients.

 

MAGEC Rod Tool

MAGEC growing rod improves orthopaedics

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MAGEC Spinal Growing Rod Inside Boy

After implanting a MAGEC Spinal Growing Rod, doctors use an external remote control to lengthen the magnetically controlled rod as the child grows.

Children’s National Health System was among the first in the country to offer a novel spinal growing rod for children with scoliosis after it was approved by the FDA just three years ago – and has now treated 30 patients with this innovative technique. The MAGEC™ (MAGnetic Expansion Control) Spinal Growing Rod is a non-invasive treatment for children with early onset scoliosis.

After the initial procedure to implant the rod, doctors use an external remote control outside of the body to lengthen the magnetically controlled rod as the child grows. The adjustments are non-invasive, reducing the number of surgeries required during the course of treatment.

Growing rods have become effective tools for children whose spinal curvature is too significant to control with bracing or casting. The rods—which are surgically attached to the spine above and below the curve and then traditionally lengthened during follow-up surgical procedures—allow the spine to continue growing while managing the curve until the child is old enough for spinal fusion.

The problem: Children must bear the physical and psychological burden of undergoing lengthening procedures every six to 12 months until they are skeletally mature enough to have spinal fusion—typically around age 10 for girls and age 12 or 13 for boys.

Now, instead of returning to the hospital for a major surgery to adjust growth rods twice a year, children with the MAGEC rod have adjustments in just a few minutes four times a year – minus invasive surgery and recovery time, says Matthew Oetgen, M.D., Division Chief of Orthopaedic Surgery and Sports Medicine and Director of Orthopaedic Research at Children’s National.

“Traditional growing rods work, but they require multiple surgeries that increase complication rates and time spent in the hospital,” he says. “We treat many children each year who have or are candidates for growing rods, so it’s important for us to embrace new technology to make the lengthening process easier and less painful for children while decreasing morbidity.”

Children’s National orthopaedic surgeons lengthen the MAGEC rod every three to four months in the office using the electronic remote control. They then monitor the scoliosis and treatment progress with radiographs. Like traditional growing rods, MAGEC is a means, not an end—the system provides a bridge treatment spanning the years between the initial lengthening surgery and spinal fusion.

Dr. Oetgen says this game-changing technology may not be the right solution for every patient, but is the preferred choice because the patients can avoid some additional surgeries down the line. Patients in the 5-7 year age range at the time the rod is in place would potentially face 10 years of surgeries every six months with traditional growing rods.

“We’ve eliminated these regularly scheduled procedures, which is great if you’re a healthy kid,” Oetgen says. “But if you are a kid with other health challenges, such as a neuromuscular disease – it’s really life changing not to have to go into surgery every six months. It saves them a tremendous amount of intervention.”

Following MAGEC’s approval by the U.S. Food and Drug Administration in February 2014, surgeons at Children’s National performed two of the first 15 MAGEC implantations in the country, and the first in the greater Washington, DC, area. MAGEC rods are approved for children with scoliosis greater than 50 degrees in magnitude and under 10 years of age.

On the horizon for this new technology are some improvements Oetgen says would allow physicians using MAGEC rods to improve the patient experience even more. “Smarter” devices could potentially tell doctors how much lengthening has actually occurred after they’ve pushed the buttons on the remote control – instead of having to follow up the procedure with an x-ray to see how the rod interacted with soft tissue around the spine, he says.

And the next generations of MAGEC rods may be smaller devices, allowing younger, smaller kids to reap the benefits.

“In the future these improvements will allow us to treat more patients, and allow us to know what we’re doing and what kind of feedback we’re getting,” Oetgen says.

It took an act of Congress to save lives

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Boosting research and innovation to find cures and develop new medical devices for children and adults who carry childhood and rare diseases will transform our health system and save lives.

Until now, medical research and innovation have been severely limited in the U.S. by regulations and lack of funding. On behalf of healthcare systems and medical innovators across the U.S., we applaud the House and Senate for their tremendous bipartisan effort to pass the 21st Century Cures Act that will transform our health and research system and enable us to more effectively fight diseases.

We are encouraged by the provisions in the act that break down regulatory barriers and expedite the approvals of drugs and devices. We are particularly excited about the provisions to increase funding to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), as well as the establishment of precision medicine, the cancer moonshot initiatives and new programs that will improve our mental health system and fight the worsening opioid epidemic. Boosting research and innovation to find cures and develop new medical devices for children and adults who carry childhood and rare diseases is at the core of our mission at Children’s National. Our researchers are working to find new biomarkers, map the human genome, develop medical devices for children and personalize medicine to make treatment and cures more targeted and effective. They are also studying pain and looking at new ways to detect the presence of opioids and cannabinoids. Thanks in large part to funding from the NIH, institutions like ours are able to continue groundbreaking biomedical research. This legislation brings hope to our children and their families, especially those who volunteer to participate in research, that our scientific breakthroughs will be translated to drugs, therapeutics and medical devices safer and faster.

Another victory for all of us in the pediatric medical device field is the expansion of the Humanitarian Use Device program to include devices used by up to 8,000 individuals rather than the current 4,000 individual cap. The hard cap at 4,000 individuals was excessively restrictive and was a significant disincentive blocking the development of devices for rare diseases and conditions, especially those affecting children. The 4,000 limit was also an obstacle for the development of diagnostic devices, since the FDA interprets the limitation to apply to the number of patients that would receive the diagnostic test, rather than the number of individuals affected or manifesting the rare disease.

Currently, medical device development for children lags woefully behind adults. Children have medical device needs that are considerably different from adults. The subtleties of developing devices for pediatric patients are fundamentally different than those for adults. The challenges include small markets, scarce financial incentives, regulatory issues, and the procedural dissimilarities of premarket clinical trials and post-market surveillance. The lack of available pediatric devices often forces clinicians to treat pediatric patients by using or modifying adult devices, adjusting implants designed for other purposes, and using implants designed decades ago. Because devices are being used “off-label,” clinicians and regulators are not able to collect information on their effectiveness. This act promises a faster regulatory approval process, which increases the enthusiasm of the venture community in investing in drug and device development, which in turn can help startup companies in the field secure private capital.

Thank you to everyone who worked tirelessly to create this bill and to those who lobbied on its behalf. It’s efforts like the 21st Century Cures Act, that break down regulatory barriers and provide the resources to expedite the approvals of life-saving drugs and devices, that save children’s lives.

About the Author

Kolaleh Eskandanian, Ph.D.
Executive Director
Sheikh Zayed Institute for Pediatric Surgical Innovation
Research interests: device development, entrepreneurship, innovation in health care

Study to evaluate heat-activated chemotherapy drug

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Children’s National Health System and Celsion Corp., a leading oncology drug-development company, will be the first to launch a clinical study in the U.S. that evaluates the use of ThermoDox®, a heat-activated chemotherapy drug, in combination with noninvasive magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) to treat refractory or relapsed solid tumors in children and young adults.

The investigator-sponsored Phase I study, which is partially funded by an NIH R01 grant, will determine a safe and tolerable dose of ThermoDox, a lyso-thermosensitive liposomal doxorubicin (LTLD), which can be administered in combination with MR-HIFU. Under the guidance of an MRI, the high-intensity focused ultrasound directs soundwave energy to heat the tumor and the area around the tumor. When heated, the liposome rapidly changes structure and releases doxorubicin directly into and around the targeted tumor.

“There is currently no known cure for many patients with refractory recurring solid tumors, despite the use of intensive therapy, so we need to identify new, smarter therapies that can improve outcomes,” said AeRang Kim, M.D., Ph.D., oncologist and member of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National, who is also principal investigator for the study. “Recent advances in the use of noninvasive MR-HIFU coupled with novel therapies, such as LTLD, may provide us with a mechanism to noninvasively administer high concentrations of the drug directly to the site where it is most needed and avoid toxicity to other areas of the body.”

A First to Treat Childhood Cancer

This is the first time LTLD is being combined with MR-HIFU and the first time it is being evaluated in children.

“Celsion’s experience in combining ThermoDox with HIFU, a noninvasive next generation heating technology, supports this very important research in childhood cancers. From a safe dose, ThermoDox’s proven ability to deliver high concentrations of an effective chemotherapy directly to a heated tumor makes it an ideal candidate for a trial involving children and young adults,” said Michael H. Tardugno, Celsion’s chairman, president and CEO. “This study will further elucidate ThermoDox’s potential in combination with ultrasound-induced hyperthermia, and highlight potential applications of ThermoDox in combination with a broad range of heating technologies that could address an even larger population of patients.”

A Multidisciplinary Approach

The study targeting the treatment of childhood sarcomas will be carried out as a multidisciplinary collaboration between Children’s National, Celsion, and Dr. Bradford Wood’s team at the National Institutes of Health.

This is the latest study from the Image-Guided Non-Invasive Therapeutic Energy (IGNITE) program, a collaboration of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National and the pediatric health system’s Divisions of Radiology, Oncology, Surgery, and Anesthesiology. The goal of the IGNITE program is to improve the quality of life and outcomes for pediatric patients through the development and clinical introduction of novel minimally invasive and noninvasive surgery technologies and combination therapy approaches. In 2015, doctors from Children’s National were the first in the U.S. to treat osteoid osteoma, a benign and painful bone tumor, using MR-HIFU.

ThermoDox is currently in late-stage clinical trials in primary liver cancer and recurrent chest wall breast cancer. It is positioned for use with multiple heating technologies, and has the potential for applications in the treatment of other forms of cancer including metastatic liver and nonmuscle invading bladder cancers.

Minimally invasive surgery brings lasting relief to pediatric achalasia patients

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Achalasia affects only a small number of people around the world, estimated at 1.6 per 100,000, and children make up fewer than 5 percent of that total. In most cases, the causes are unknown, but it is attributed to a combination of heredity and autoimmune or nerve cell disorders. For adults, treatment might include oral medication to prevent narrowing, balloon dilation, or botulinum toxin injections to relax the muscle at the end of the esophagus. For a growing child, who faces not just months but a lifetime of injections and potential repeat procedures, these methods aren’t viable. Instead, surgical correction is the standard of care. In the past 10 years, the surgical option evolved from a traditional open procedure with weeks of recovery and pain to less-invasive approaches.

“The total number of children with achalasia is small,” says Timothy D. Kane, M.D., Division Chief of General and Thoracic Surgery at Children’s National Health System. “But Children’s National treats more of these cases than most other children’s hospitals around the world, and that gives us the ability to look at a larger population and see what works.”

Dr. Kane is senior author of a study recently published in the Journal of Pediatric Surgery that analyzed the outcomes from nearly a decade’s worth of these cases to gauge the effectiveness of two different minimally invasive surgical approaches for children with achalasia.

A look at the two surgical options

The most common surgical intervention is laparoscopic Heller myotomy, performed through small incisions in the belly. Additionally, Dr. Kane and the Children’s surgical team are one of only two teams in the country who perform a different procedure called peroral endoscopic myotomy (POEM) on children. The POEM procedure is completed entirely through the mouth using an endoscope, with no additional incision needed. The procedure is commonly used for adult achalasia cases, but is not widely available for children elsewhere as it requires specialized training and practice to perform.

“Heller myotomy works very well for most kids — that’s why it’s the standard of care,” Dr. Kane says. “Our study found that patients who underwent the POEM procedure experienced the same successful outcomes as Heller patients, and we already knew from adult data that POEM patients reported less pain following surgery — a win-win for children.”

The retrospective study included all children who had undergone surgical treatment for achalasia at Children’s from 2006 to 2015. Since achalasia cases are few and far between, with most children’s hospitals seeing maybe one to five cases over 10 years, collecting reliable data on outcomes is challenging. This study provides a large enough sample to allow doctors to use the findings as a guide to find the interventions that are the best fit for each patient.

“Now we’re very comfortable presenting families with two really good options and letting them choose the one that works best for them,” he concludes.

Imagine the feeling of food stuck in your throat. For children with esophageal achalasia, that feeling is a constant truth: The muscles in the esophagus fail to function properly and the lower valve, or sphincter, of the esophagus controlling the flow of food into the stomach doesn’t relax enough to allow in food — causing a backup, heartburn, chest pain, and many other painful symptoms. For children, surgery is the best hope for permanent relief.

Smart Tissue Autonomous Robot (STAR)

Popular Science awards smart tissue autonomous robot

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Technology developed in the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National has been named one of the 12 Most Important Health Innovations of the Year in the November/December 2016 issue of Popular Science. Smart Tissue Autonomous Robot (STAR), a technology that performed the first supervised, autonomous robotic soft tissue surgery on a live subject (in vivo) this year, has been awarded a 2016 Popular Science Best of What’s New Award in the Health category.

How the smart tissue autonomous robot works

STAR removes the surgeon’s hands from the procedure, instead utilizing the surgeon as supervisor, with soft tissue suturing autonomously planned and performed by the STAR robotic system.  The system integrates near infrared florescent (NIRF) markers and 3-D plenoptic vision to provide uninhibited tracking of tissue motion. This tracking is combined with an intelligent algorithm that autonomously adjusts the surgical plan in real time as tissue movements occur.

About Popular Science health innovations of the year

Each year, the editors of Popular Science review thousands of products in search of the top 100 tech innovations of the year—breakthrough products and technologies that represent a significant leap in their categories.

The Best of What’s New awards honor the innovations that shape the future,” says Kevin Gray, Executive Editor, Popular Science. “From lifesaving technology to incredible space engineering to gadgets that are just breathtakingly cool, this is the best of what’s new.”

3 ways to bring safe surgery to kids in remote regions

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On Oct. 10, at the World Federation of Pediatric Surgeons (WOFAPS) Congress, in Washington, DC, the chief executives of four top North American pediatric hospitals held a candid discussion about bridging gaps in access to safe, high-quality surgical care for children everywhere. Below are three key strategies that emerged from the conversation.

1. Deploy innovative technologies

Kurt Newman, M.D., president and CEO of Children’s National Health System, kicked off Monday’s panel by describing a so-called innovation paradox. Game-changing innovations in pediatric medicine, he said, often emanate from both ends of the global development spectrum.

First-world technologies–such as telemedicine and remote robotics–developed in affluent regions are bringing important specialized care opportunities to lower-resourced communities. At the same time, pressures experienced in developing regions to adapt to challenging conditions and resource constraints can lead to creative solutions with implications well beyond the third world.

According to Michael Apkon, M.D., CEO of the Toronto-based Hospital for Sick Children, up to 85 percent of children in the developed world are cared for in emergency departments that have no specific in-house pediatric expertise. For the most part, he said, they are treated in general hospitals by physicians and nurses with no specific training in pediatric care.

In remote areas like rural Ontario, there simply isn’t enough volume to sustain in-house pediatric specialists in every hospital, Apkon explained, “but there’s a big opportunity to provide support from centers that do have that capacity.” Through telemedicine and remote robotics, “we can guide caregivers that are quite capable of doing interventions if they have the right support,” he said.

At the same time, technologies created to meet specific third-world needs are demonstrating potential for broader applications.

Dr. Newman highlighted one such technology – a low-cost, disposable, multifunctional incubator for at-risk, low-birth-weight babies – developed by the Center for Advanced Sensor Technology at University of Maryland Baltimore County. The technology won a major grant earlier this week as part of a device competition at the 4th annual Sheikh Zayed Pediatric Surgical Innovation Symposium.

Though it was developed specifically to help curb preventable deaths within the first week of birth in developing areas, the technology could have cost-reducing applications for hospitals around the world.

2. Provide training opportunities

Richard Azizkhan, MD, CEO of Children’s Hospital & Medical Center in Omaha, spent the early decades of his career working to reconstruct a functioning health care system in post-war Bosnia. A key starting point, he said, was building infrastructure for training and education.

For several years during the war, there were simply no training opportunities for in-country physicians and nurses, he explained. Working with colleagues, Azizkhan set up educational exchange programs and academic centers to teach skills in minimally invasive surgery and other modern techniques. Over time, trainees become trainers, and those skills propagated widely.

“I was training people who ultimately ended up becoming much better than I was,” said Azizkhan. “The first person I trained ended up doing more than 400 cases and becoming a leading trainer for the entire Balkans region.”

Success didn’t happen overnight. “It took literally 20 years to build that infrastructure,” he said. But today the country has capacity for very sophisticated care, including transplants and neonatal oncology.

Dr. Apkon echoed the value of training opportunities for care providers in under-resourced regions.

“Parts of the world that are blessed with the ability to have a specialized system have a moral obligation to help in whatever way they can to create capacity where it doesn’t yet exist,” he said.

Through the SickKids-Ghana Initiative, 1500 nurses in Ghana are being trained to provide very basic services in rural communities that lack a developed healthcare system. The work is aimed at training nurses in foundational elements of holistic pediatric care, including administering treatments for low oxygen, dehydration, and low blood sugar.

3. Build partnerships – locally and globally

In his former capacity at the Cleveland Clinic, Marc Harrison, MD, incoming CEO of Intermountain Healthcare, was tasked with building an entire new multispecialty hospital in Abu Dhabi.

When asked about the key to his success, Harrison didn’t hesitate.  “The biggest thing we did right was have the right partner,” he said.

Working with the Crown Prince of Abu Dhabi and many other local partners, Harrison gained insights about how health care is delivered in the region and any societal and political considerations that could impact the hospital’s operations.

“If you’re coming into a new place and are too arrogant to see that there are those who understand the environment better than you, you will fail,” he said. “It isn’t enough to have technical skills or a long track record … if you don’t have the ability to get things done on the ground, you won’t succeed.”

Dr. Azizkhan also emphasized the importance of partnerships – not just locally but globally.

In North America, he pointed out, over 100 institutions are working together to share data and best practices to improve quality and safety across systems. Ventilator-associated pneumonias, central line infections, and surgical site infections, he said, can be dramatically reduced by sharing best practices.

Dr. Newman closed the panel noting, “One thing I’ve found through my career as a surgeon,” he said, “is that the community of cooperation, friendship, and collaboration among pediatric surgeons is unparalleled.”

pediatric medical device competition winners

Winning innovators of pediatric medical device competition announced

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The Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System hosted the 4th annual Pediatric Surgical Innovation Symposium on Oct. 8. One of the highlights: Six pediatric medical device innovations that address a significant unmet need were awarded a total of $250,000 in grant money by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI).

Kurt Newman, M.D., President and CEO of Children’s National said: “Even though they are a small portion of the patient population, it’s critical for children to have medical devices that are built specifically for them. Children’s National is committed to bringing together the key stakeholders including innovators, clinicians, policy makers, and investors, to support advancements in the care of children.”

“We are honored to recognize these exciting innovations with this funding,” said Kolaleh Eskandanian, Ph.D., Executive Director of NCC-PDI and the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National. “It takes millions of dollars to bring a device to market and our program provides the funding needed to bridge the critical gap that often follows the prototyping phase in life cycle of the device.”

       Winning innovations receiving $50,000 awards are:

  • Maternal Life, Palo Alto, Calif. – low-cost closed system that captures and administers colostrum to newborns with zero percent loss
  • JustRight Surgical, Louisville, Colo. – second generation surgical 5mm stapler scaled for a wider range of pediatric surgical procedures and bringing the benefits of laparoscopy to patients
  • Lully, San Francisco – moisture sensor and Smart Pod monitor wirelessly connected to a smartphone app to prevent bedwetting episodes
  • Center for Advanced Sensor Technology, University of Maryland Baltimore County, Baltimore – low-cost, disposable multifunctional incubator for at-risk, low-birth-weight babies

Winning innovations receiving $25,000 awards are:

  • Nebula Industries, Melrose, Mass. – quick-release medical tape to prevent neonatal and pediatric skin injuries
  • May & Meadow, Inc., Redwood City, Calif. – low-cost, mobile medical device for assessing feeding ability in infants at risk for feeding problems

11 Children’s National surgeons and physicians to participate at WOFAPS 2016

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Pediatric surgeons, physicians, and scientists from around the world are meeting in the nation’s capital Oct. 8 to 11 , for the 5th World Congress of the World Federation of Associations of Pediatric Surgeons (WOFAPS) hosted by The Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. It’s the first time that the meeting will be in North America. This year’s theme is “re-imagining children’s surgery through global innovation and integration.”

The 5th WOFAPS congress includes many scientific and research plenary sessions by pediatric surgical experts from around the world. Eleven Children’s National and Sheikh Zayed Institute surgeons and physicians are participating in panels covering different topics and areas of expertise including:

  • Minimally Invasive Surgery: Current State of Endoscopic & Minimally Invasive Bariatric Surgery
  • The Current Standards of Management & Controversies in Pediatric Tumors: Neuroblastoma & Wilms Tumor
  • Per Oral Endoscopic Myotomy (POEM) Techniques for Pediatric Achalasia: Approach, Techniques & Setting up Program
  • Hot Topics in Pediatric Urology: Controversies & Advances

Pediatric surgical innovation symposium approaches

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This year, there were a record number of entries (91) for the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) competition, which will be held  Oct. 8 at the fourth annual Pediatric Surgical Innovation Symposium, hosted by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. Twelve finalists have been selected to pitch their pediatric medical device innovation, and up to six innovations will be awarded up to $50,000 each, with awards based on presentations given before a panel of expert judges.

The finalists are:

  • PECA Labs, Pittsburgh, Pa. – synthetic vascular conduit for surgical repair of congenital heart defects that’s capable of minimally invasive, controlled expansion to grow with the patient
  • Maternal Life, Palo Alto, Calif. – low-cost closed system that captures and administers colostrum to newborns with zero percent loss
  • Magnamosis, Inc., San Francisco, Calif. – device to provide safer, less invasive repair of the esophagus in newborns with esophageal atresia/tracheoesophageal fistula, a condition requiring surgery that is currently performed by hand
  • JustRight Surgical, Louisville, Colo. – second generation surgical 5mm stapler sized for use with a wider range of pediatric surgical procedures and bringing the benefits of laparoscopy to patients
  • CareTaker Medical, Charlottesville, Va. – disposable, finger cuff for single patient use to continuously and non-invasively monitor neonatal  heart rate without adhesives, electrodes and wires
  • Nebula Industries, Melrose, Mass. – quick release medical tape to prevent neonatal and pediatric skin injuries
  • Lully, San Francisco, Calif. – moisture sensor and Smart Pod monitor, placed under the mattress, that are wirelessly connected to a smartphone app to prevent bedwetting episodes
  • Center for Advanced Sensor Technology, University of Maryland Baltimore County, Baltimore, Md. – low-cost, disposable multifunctional incubator for at-risk, low birth weight babies
  • Multisensor Diagnostics, Baltimore, Md. – non-invasive portable handheld device designed to perform rapid medical assessment of key vitals for pediatric patients
  • May & Meadow, Inc., Redwood City, Calif. – low-cost, mobile medical device for assessing feeding ability in infants at risk for feeding problems
  • PediaStent, Cleveland, Ohio – novel pediatric bioresorbable stent for use in repairing congenital heart lesions
  • Averia Health Solutions, Alexandria, Va. – low-cost concussion screening and management system that uses smartphone technology

“The impressive number of well qualified applications we received from all over the US as well as from other countries speaks to the enthusiasm of Medtech innovators to develop and test devices specifically for children,” said Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., Executive Director of the Sheikh Zayed Institute for Pediatric Surgical Innovation and NCC-PDI. “We are committed to building on this momentum and keeping the conversation going with all who applied and will provide consultation services if needed.”

Read more.