Sam Brusco, Associate Editor09.12.23
Insightec has gained additional CE mark approval for essential tremor treatment using its Exablate Neuro platform.
The new EU nod allows appropriate patients to have their second side treated at least nine months following treatment of the first side, which the company said could potentially relieve tremor on both sides of the body.
An Insightec-sponsored clinical trial for unilateral treatment in those qualified for the bilateral procedure showed a “highly significant reduction” in tremor after treating the second side with Exablate Neuro. The results were immediate and sustained through a minimum six months of follow up, which the company said was consistent with results for treatment of the first side.
Further, Insightec reported “significant improvement” in functional disability, suggesting a clinically meaningful effect in daily activities like eating, drinking, and writing. The company said the majority of adverse events were mild and had a similar profile to treatment of the first side.
"This CE mark approval is a very important milestone for us and demonstrates our unwavering commitment to expanding the treatment options that can improve the quality of life for people living with essential tremor," Maurice R. Ferré, MD, chairman and CEO at Insightec, told the press. "Many patients who've benefited from tremor reduction from the first side treatment ask about having the second side treated. This approval paves the way for them to do that."
"Since its approval in the U.S., both patients and physicians in Europe have eagerly been awaiting its availability," added Giuseppe Carbone, VP of Insightec, Europe. "With this approval, patients can potentially avoid the decision of having to choose which side should be treated. It is exciting to provide a whole treatment and enable people living with essential tremor to feel complete."
The new EU nod allows appropriate patients to have their second side treated at least nine months following treatment of the first side, which the company said could potentially relieve tremor on both sides of the body.
An Insightec-sponsored clinical trial for unilateral treatment in those qualified for the bilateral procedure showed a “highly significant reduction” in tremor after treating the second side with Exablate Neuro. The results were immediate and sustained through a minimum six months of follow up, which the company said was consistent with results for treatment of the first side.
Further, Insightec reported “significant improvement” in functional disability, suggesting a clinically meaningful effect in daily activities like eating, drinking, and writing. The company said the majority of adverse events were mild and had a similar profile to treatment of the first side.
"This CE mark approval is a very important milestone for us and demonstrates our unwavering commitment to expanding the treatment options that can improve the quality of life for people living with essential tremor," Maurice R. Ferré, MD, chairman and CEO at Insightec, told the press. "Many patients who've benefited from tremor reduction from the first side treatment ask about having the second side treated. This approval paves the way for them to do that."
"Since its approval in the U.S., both patients and physicians in Europe have eagerly been awaiting its availability," added Giuseppe Carbone, VP of Insightec, Europe. "With this approval, patients can potentially avoid the decision of having to choose which side should be treated. It is exciting to provide a whole treatment and enable people living with essential tremor to feel complete."