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Home » Insightec touts 1st patient treated in Exablate Neuro FDA feasibility trial

Insightec touts 1st patient treated in Exablate Neuro FDA feasibility trial

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Insightec

Insightec today announced that the 1st patient has been treated in a feasibility trial exploring the use of its Exablate Neuro system for treating benign centrally-located intracranial tumors in pediatric and young adults.

The Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull.

A team at the Nicklaus Children’s Hospital performed the 1st procedure on a 21-year old patient suffering from seizures associated with a benign hypothalamic hamartoma brain tumor.

“This breakthrough first procedure sets the stage for us to provide incisionless surgery for young patients with benign centrally-located brain tumors. Our team is encouraged by the potential of focused ultrasound technology to positively impact lives,” Dr. Prasanna Jayakar of the Brain Institute at Nicklaus Children’s Hospital said in a prepared statement.

“We applaud the team at Nicklaus Children’s for their commitment to treating children with various brain conditions. Their pioneering research with our MRgFUS technology offers hope that significant groups of pediatric patients will be able to undergo treatment without any surgical incision, minimizing or eliminating the risk of infection or other surgical complications,” Insightec chair & CEO Dr. Maurice Ferré said in prepared remarks.

“The needs of pediatric patients emphasize some of the important advantages of focused ultrasound. It is incisionless, avoids ionizing radiation, offers less risk of infection and disruption of adjacent normal tissue than surgery, and patients often return to normal activities within days. These benefits are especially important in neurosurgery, and researchers around the world are investigating other areas where this innovative care could improve outcomes for patients of all ages. The Foundation congratulates the entire team of Nicklaus Children’s Hospital and Insightec for this breakthrough achievement,” Focused Ultrasound Foundation chief medical officer Dr. Tim Meakem said in a press release.

Last December, Insightec announced 2 regulatory wins, receiving CE Mark approval in the European Union for its Exablate Prostate for treating locally-confined prostate cancer and Japanese approval for its Exablate Neuro for treating essential tremor.

The Exablate Prostate system uses focused ultrasound to target and ablate tissue in the prostate while minimizing damage to adjacent structures, the company said.

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