Expanded indication of incisionless Exablate Neuro platform offers new hope for 50,000+ patients
Insightec, a global healthcare innovator dedicated to using focused ultrasound to transform patient care, announced that the U.S. Food and Drug Administration (FDA) has approved the use of its Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients living with advanced Parkinson’s disease (PD).
This new indication covers both the initial and the subsequent staged procedure, enabling comprehensive bilateral treatment. This provides an expanded therapeutic option for patients suffering from severe motor symptoms such as rigidity, bradykinesia, and dyskinesia due to PD who haven’t found relief from medication.
Health Technology Insights: US Healthcare Giant Expands Sectra Cloud for Cancer Diagnostics
“This milestone reflects our commitment to expanding access to safe, effective, and incisionless treatment options for people living with Parkinson’s disease,” said Maurice R. Ferré, MD, CEO and Chairman of Insightec. “With this new indication, we’re advancing care for movement disorders and opening the door to life-changing treatment for those who need it now and in the years ahead.”
Exablate Neuro uses focused ultrasound to precisely treat targeted areas in the pallidothalamic tract, guided by MRI. The procedure is incisionless, does not require implanted hardware, and offers a lower risk profile compared to traditional surgical interventions.
“This new indication represents a significant step forward in how integrated movement disorder teams will approach the treatment of Parkinson’s disease,” said Dr. Michael Kaplitt, Department of Neurological Surgery, Weill Cornell Medicine-New York Presbyterian Hospital. “As the lead investigator of the clinical trial evaluating the safety and effectiveness of the staged bilateral procedure with the Exablate system, I’m encouraged by the results and am excited about what it offers my patients.”
Health Technology Insights: DoH, USCF and IGI Explore Establishing the World’s First-Of-Their Kind Centres for Genome Surgery
The clinical trial, conducted at nine centers across the U.S., Europe and Asia, demonstrated encouraging outcomes that played a key role in supporting FDA approval. Full results from the study are expected to be published later this year.
PD is expected to affect more than 1.2M Americans by 2030. While medications remain the first line of treatment, many patients eventually experience side effects or diminishing efficacy, prompting the need for additional treatment options. Insightec plans a limited launch of the bilateral procedure in select centers during 2025, along with ongoing efforts to establish routine reimbursement pathways to ensure broader patient access.
“The ability of MR-guided focused ultrasound to precisely target both sides of the brain and improve disabling symptoms, without the need for a surgical incision or anesthesia, offers new hope for persons with Parkinson’s disease,” said Dr. Arif Dalvi, Director, Comprehensive Movement Disorders Center, Palm Beach Health Network and top-enrolling investigator.
The Exablate Neuro platform previously received FDA approval for unilateral treatment of medication-refractory essential tremor in 2016, tremor-dominant PD in 2018, unilateral pallidotomy for Parkinson’s-related dyskinesia and motor symptoms in 2021 and staged unilateral treatment for ET patients on for the contralateral (second) side.
To date, more than 25,000 patients have been treated with Insightec’s Exablate technology for a variety of movement disorder indications at 197 centers worldwide, including 84 in the U.S.
Health Technology Insights: BioDlink Drives Global Biologics Innovation with Ecosystem Partners
To participate in our interviews, please write to our HealthTech Media Room at sudipto@intentamplify.com
Source – PR Newswire
