Nicklaus Children's Hospital Performs World's First Focused Ultrasound Surgery on Hypothalamic Hamartoma Tumor in Epilepsy Patient

The procedure to target the benign hypothalamic hamartoma brain tumor, conducted on March 7, was performed using INSIGHTEC's Exablate Neuro system. The procedure is performed in a magnetic resonance imaging (MRI) suite and uses high intensity focused ultrasound waves to precisely target and destroy the targeted tumor in the brain. MRI provides high resolution visualization of the patient's anatomy as well as near real-time monitoring. This marriage of technology allows surgeons to precisely heat and destroy the target tumor, without impacting the scalp, skull or surrounding healthy brain tissue.

Following the procedure, high-resolution MRI scans of the patient, a 21-year-old student, show complete ablation of the tumor. The patient was able to return home the following day, resume classes and she remains seizure free. Patients undergoing standard brain surgery to remove similar tumors are typically hospitalized for several days, require sutures, and are at risk of bleeding and infections. 

"Congratulations to the team at Nicklaus Children's for another first with our MR-guided focused ultrasound technology. We are committed to supporting research efforts such as these that push the boundaries of our technology to treat more and more patients," said Maurice R. Ferré MD, CEO and Chairman of INSIGHTEC.

Prasanna Jayakar, MD, PhD, Chairman of the Nicklaus Children's Brain Institute, said, "The Brain Institute is very honored to have been able to partner with INSIGHTEC to conduct a study of the safety of this novel methodology in children. Our program has an extensive multispecialty team, all dedicated to innovating the safest, least invasive methods to offer a better future for children with brain tumors and seizure-causing brain tissue. It is our hope that this contributes to knowledge that leads to enhanced treatment for children worldwide."

The medical and research team at Nicklaus Children's is led by Dr. John Ragheb, Director Division of Neurosurgery; Dr. Travis Tierney, Principal Investigator; Dr. Ian Miller, Director of Epilepsy Program; Dr. Sanjiv Bhatia, neurosurgeon; Dr. Nolan Altman, Director of Radiology; Dr. Prasanna Jayakar; and Dr. Jennifer McCafferty, Director of Research, Miami Children's Research Institute.

The study is funded by Nicklaus Children's Hospital, with support from the Focused Ultrasound Foundation. 

"Expanding focused ultrasound's reach into pediatrics is an important milestone for the technology," said Foundation Chairman Neal F. Kassell, MD. "It has been proven safe and effective in ablating tissue in the adult brain for movement disorders, and it is being investigated for soft tissue tumors and painful bone tumors in younger patients. We look forward to continuing to work with Nicklaus Children's and other sites worldwide to advance this innovative care for children."

Hypothalamic hamartoma is a rare, benign (non-cancerous) brain tumor that can cause different types of seizures, cognitive problems or other symptoms. While the exact number of people with hypothalamic hamartomas is not known, it is estimated to occur in 1 out of 200,000 children and teenagers worldwide.

The Brain Institute's Epilepsy Program, founded in 1980, is an international leader in the diagnosis, and medical and surgical treatment of pediatric epilepsy, offering treatment options available at only a handful of centers worldwide. Program highlights include patient access to new and emerging medications for epilepsy management as well as surgical interventions – including minimally invasive methods – for children with medically resistant epilepsy. Epilepsy surgery is supported by advanced brain mapping techniques that promote optimal preservation of healthy brain tissue, contributing to patient safety and outcomes that are among the best in the world.

For more information, please see the ClinicalTrials.gov website at https://clinicaltrials.gov/ct2/show/NCT03028246 or call Miami Children's Research Institute at 305-496-4188.

About Nicklaus Children's Hospital
Founded in 1950 by Variety Clubs International, Nicklaus Children's Hospital – part of Miami Children's Health System – is South Florida's only licensed specialty hospital exclusively for children, with more than 740 attending physicians and over 220 pediatric subspecialists. The 289-bed hospital is renowned for excellence in all aspects of pediatric medicine with several specialty programs routinely ranked among the best in the nation by U.S. News & World Report. The hospital is also home to the largest pediatric teaching program in the southeastern United States and has been designated an American Nurses Credentialing Center (ANCC) Magnet facility, the nursing profession's most prestigious institutional honor. For more information, please visit www.nicklauschildrens.org.

About INSIGHTEC
INSIGHTEC is the world leader and innovator of MR-guided Focused Ultrasound (MRgFUS). The company's non-invasive therapy platforms, Exablate and Exablate Neuro, are proven technology based on sound clinical evidence for treating essential tremor, painful bone metastases and uterine fibroids. The company is dedicated to improving patient lives by collaborating with physicians, medical institutions, academic researchers and regulatory bodies around the world. For more information, please visit:www.insightec.com.

About the Focused Ultrasound Foundation
The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development of focused ultrasound, an early-stage, noninvasive, therapeutic technology with the potential to transform the treatment of many serious medical disorders. The Foundation works to clear the path to global adoption by coordinating and funding research, fostering collaboration, and building awareness among patients and professionals. It is dedicated to ensuring that focused ultrasound finds its place as a mainstream therapy for a range of conditions within years, not decades. Since its establishment in 2006, the Foundation has become the largest non-governmental source of funding for focused ultrasound research. More information can be found at www.fusfoundation.org.

For more information:
Rachel Perry – 305-663-8476

SOURCE Nicklaus Children's Hospital

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