FDA grants new approval for essential tremor treatment from Insightec

Insightec announced today that it received additional FDA approval for treating essential tremor with its Exablate Neuro platform.

Essential tremor commonly affects both sides of the body, Insightec noted in a news release. The new approval allows appropriate patients to receive treatment on their second side at least nine months after treatment of the first side.

Exablate Neuro uses focused sound waves safely guided by MRI. It provides tremor treatment to patients with medication-refractory essential tremor and Parkinson’s disease.

“This FDA approval is a very important milestone for us and demonstrates our unwavering commitment to expanding the treatment options for people living with essential tremor,” said Dr. Maurice R. Ferré, CEO and chair of the board of directors at Insightec. “It’s very common for patients who’ve benefited from tremor reduction from the first side treatment to ask about having the second side treated. This approval paves the way for them to do that.”

How Insightec garnered its latest FDA approval
Insightec said its sponsored study included 51 patients across seven U.S. centers. It evaluated Exablate Neuro for safety and efficacy endpoints out to six months.

Data demonstrated a highly significant reduction in tremor following treatment of the patients’ second side. Results proved immediate and sustained through at least six months of follow-up. According to Insightec, this falls in line with results from the treatment of the first side.

Insightec said the study demonstrated a significant improvement in functional disability. This suggests a clinically meaningful impact on activities of daily living. That includes eating, drinking and writing.

Patients reported the majority of adverse events in the study as mild. Exablate Neuro demonstrated a similar safety profile in treating the second side as it did for the first side.

“We are happy to have an option for patients with essential tremor to ultimately receive focused ultrasound treatment on both sides of the brain,” said Dr Michael G. Kaplitt, professor and executive vice-chair of neurological surgery, New York Presbyterian Hospital-Weill Cornell Medicine, and principal investigator of this study. “The investigators are working with Insightec to share the full results of the study with the professional community in an academic publication to further help practitioners guide their patients going forward.” MassDevice