Insightec has received additional CE Mark approval for its Exablate Neuro platform for the treatment of essential tremor, which typically affects both sides of the body, allowing eligible patients to receive treatment on the second side at least nine months after treatment on the first side, potentially providing relief of tremor on both sides of the body.
Affecting approximately 60 million people globally, essential tremor is the most common movement disorder in the world and is often misdiagnosed as Parkinson’s disease.
Efficacy of treatment. The Insightec-sponsored study included patients in a multi-center, randomized clinical trial for unilateral treatment, who qualified for bilateral procedure. Data from the study showed a highly significant reduction in tremor following treatment of the second side. These results were immediate and sustained through at least six months of follow up, consistent with results of treatment from the first side. In addition, there was a significant improvement in functional disability, suggesting a clinically meaningful effect in activities of daily living such as eating, drinking, and writing. The majority of adverse events were mild, with 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,” said Maurice R. Ferré, MD, CEO and Chairman of the Board of Directors at Insightec. “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 US, both patients and physicians in Europe have eagerly been awaiting its availability,” explains 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.”