- CE mark approval follows the US FDA approval from December 2022.
- Treatment can enable qualifying patients to have their second side treated at least nine months after first side.
- Essential tremor is the most common movement disorder, affecting approximately 60 million people globally.
MÜNCHEN, Germany, 12 September 2023 – Insightec, a global healthcare company specialising in MR-guided focused ultrasound (MRgFUS), today announced it has received additional CE mark approval for treatment of essential tremor using its Exablate Neuro platform.
Essential tremor commonly affects both sides of the body, and this new CE mark approval will allow appropriate patients to have their second side treated at least nine months after treatment of the first side, potentially meaning tremor relief 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-centre, 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.”
Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company’s Exablate Neuro platform focuses sound waves, safely guided by MRI, to provide tremor treatment to patients with medication-refractory Essential Tremor and Parkinson’s Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, with offices in München, Dallas, Shanghai, and Tokyo.
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