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FDA approves MR-HIFU system to treat osteoid osteoma

Karun-Sharma-and-kids-MR-HIFU

“This FDA approval encourages and further motivates our focused ultrasound program to continue to develop and expand clinical applications of MR-HIFU in the pediatric population,”  said Karun Sharma, M.D., Ph.D.

After garnering successful clinical trial results at Children’s National Hospital, the United States Food and Drug Administration (FDA) recently announced the approval of Profound Medical’s Sonalleve MR-guided High Intensity Focused Ultrasound (MR-HIFU) system for the treatment of osteoid osteoma (OO) in the extremities. OO is a benign, but painful bone tumor that occurs most commonly in children and young adults. This marks the first focused ultrasound regulatory approval that will directly impact pediatric patients and it is the sixth indication to earn approval in the United States.

Nine patients were treated in a pilot trial designed to evaluate the safety and feasibility of MR-HIFU ablation treatment in patients with painful OO. The procedure was performed without any technical difficulties or serious adverse events in all nine patients, and resulted in complete pain relief with no further pain medication usage in eight out of nine patients.

“This FDA approval encourages and further motivates our focused ultrasound program to continue to develop and expand clinical applications of MR-HIFU in the pediatric population,” said Karun Sharma, M.D., Ph.D., director of Interventional Radiology and associate director of clinical translation at the Sheikh Zayed Institute for Pediatric Surgical Innovation (SZI) at Children’s National. “This completely non-invasive and radiation-free aspects of this therapy are especially relevant for growing children.”

Researchers at Children’s National have moved beyond OO are also evaluating MR-HIFU treatment for patients with relapsed and refractory bone and soft tissue tumors. “This is especially important as these patients don’t have any other good treatment options,” said Dr. Sharma. “For these tumors, we are using not only thermal ablation, but also other modes and biomechanisms of focused ultrasound such as mild hyperthermia to facilitate targeted, enhanced drug delivery and histotripsy (i.e., mechanical tissue fractionation) to enhance cancer immunotherapy. We also hope to move into MR-HIFU brain application in pediatrics.”

At Children’s National, a multidisciplinary team of physicians and scientists use MR-HIFU to focus an ultrasound beam into lesions to heat and destroy the tissue in that region, with no incisions at all. In 2015, Children’s National doctors became the first in the U.S. to use MR-HIFU to treat pediatric osteoid osteoma. The trial, led by Dr. Sharma, demonstrated early success in establishing the safety and feasibility of noninvasive MR-HIFU in children as an alternative to the current, more invasive approaches to treat these tumors. Since then, the Children’s National team has built an active clinical trials program and become a leader in translation of focused ultrasound for the treatment of relapsed pediatric solid tumors.

feeding tubes

NIH grant funds development of pediatric feeding tube placement device

feeding tubes

A new grant will help to finalize development of the Pediatric PUMA-G System, the world’s first and only ultrasound-based procedure for placing feeding tubes into the stomach.

Researchers at Children’s National Hospital have received grant funding from the National Institute of Diabetes and Digestive and Kidney Diseases, within the National Institutes of Health (NIH), to finalize development of the Pediatric PUMA-G System, the world’s first and only ultrasound-based procedure for placing feeding tubes into the stomach. The funding will also support the first clinical trial of this technology in pediatric patients.

“Children’s National was chosen because we have a strong record of innovating pediatric devices and surgical procedures through the Sheikh Zayed Institute and we have a busy clinical interventional radiology service,” says Karun Sharma, M.D., Ph.D., director of Interventional Radiology and associate director of clinical translation at the Sheikh Zayed Institute for Pediatric Surgical Innovation (SZI) at Children’s National. “We are proud to be a part of this collaboration that will potentially help improve care of pediatric patients who cannot tolerate feeding by mouth.”

The feeding tubes are vital for children who cannot eat or swallow and require liquid nutrition (known as enteral feeding). Common feeding tube placement procedures for children may expose them to risks from invasive surgical tools or from ionizing radiation, which may lead to cancer in young patients at elevated rates. The PUMA-G System is less invasive and uses ultrasound to help physicians image the body during the procedure.

The grant, totaling $1.6M, will clinically evaluate the Pediatric PUMA-G System in collaboration with CoapTech, a biotechnology medical device company and two other premier pediatric medical centers — New York-Presbyterian Morgan Stanley Children’s Hospital and Children’s Hospital of Philadelphia.

Karun Sharma

Children’s National designated Center of Excellence by Focused Ultrasound Foundation

Karun Sharma

“This designation provides a high level of recognition and legitimacy to the work our Children’s National team has done with MR-HIFU over many years,” says Karun Sharma, M.D., PhD, director of Interventional Radiology and associate director of clinical translation at the Sheikh Zayed Institute for Pediatric Surgical Innovation.

More precise, less invasive and less painful surgery with lower risk of complications and no radiation exposure – these are some of the benefits of treating pediatric tumors with Magnetic Resonance Guided High Intensity Focused Ultrasound (MR-HIFU). And now the Focused Ultrasound Foundation has designated Children’s National Hospital as the first global pediatric Center of Excellence (COE) for using this technology to help patients with specific types of childhood tumors.

“This designation provides a high level of recognition and legitimacy to the work our Children’s National team has done with MR-HIFU over many years,” says Karun Sharma, M.D., PhD, director of Interventional Radiology and associate director of clinical translation at the Sheikh Zayed Institute for Pediatric Surgical Innovation (SZI) at Children’s National. “This will allow our focused ultrasound program to expand to other areas of interest and become more cohesive while continuing to uncover additional clinical indications for pediatric patients.”

At Children’s National, radiologists use MR-HIFU to focus an ultrasound beam into lesions, usually tumors of the bone and soft tissues, to heat and destroy the tissue in that region. There are no incisions at all. In 2015, Children’s National doctors became the first in the U.S. to use MR-HIFU to treat pediatric osteoid osteoma, a painful, but benign, bone tumor that commonly occurs in children and young adults. The trial, led by Dr. Sharma, demonstrated early success in establishing the safety and feasibility of noninvasive MR-HIFU in children as an alternative to the current, more invasive approaches to treat these tumors. The team also conducted another clinical trial, led by AeRang Kim, M.D., Ph.D., a pediatric oncologist, to treat relapsed soft tissue tumors such as sarcomas.

Since then, the Children’s National team has built an active clinical trials program and become a leader in translation of focused ultrasound for the treatment of pediatric solid tumors. The center is currently investigating the treatment of malignant solid tumors with focused ultrasound alone and combined with chemotherapy.

“Focused ultrasound offers a number of important benefits over traditional therapies, which are especially paramount for the pediatric population,” said Focused Ultrasound Foundation Chairman Neal F. Kassell, M.D. “The team at Children’s National has an exemplary track record in using this technology to pioneer new treatment options for their patients, and we look forward to collaborating and supporting their future research.”

As a designated COE, Children’s National has the necessary infrastructure to support the ongoing use of this technology, especially for carrying out future pediatric clinical trials. This infrastructure includes an ethics committee familiar with focused ultrasound, a robust clinical trials research support team, a data review committee for ongoing safety monitoring and annual safety reviews, and a scientific review committee for protocol evaluation.

The program also features a multidisciplinary team of clinicians and investigators from SZI, radiology, oncology, surgery and orthopedics. With the new designation and continued expansion, we will expand MR-HIFU to other areas such as neuro-oncology, neurosurgery, and urology. Ongoing and future work will investigate a rational combination of MR-HIFU with local tumor drug delivery, immunotherapy and cellular therapy.

“This recognition sets us apart as a premier pediatric institution, and will allow us to pave the way to make pediatric surgery more precise and less invasive,” says Dr. Sharma.

 

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

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.”

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