India Ministry of Health and Family Welfare Approves Exablate Neuro Focused Ultrasound Platform
Insightec, a global healthcare company focused on transforming patient care, announced its incisionless neurosurgery platform, the Exablate® 4000, has received market approval by the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare of India.
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The Exablate 4000 (Exablate Neuro) platform uses MR-guided focused ultrasound to precisely ablate a small target deep within the brain without incisions. The approval will enable treatment of patients in India living with Essential Tremor, Tremor-dominant Parkinson’s Disease and Neuropathic Pain.
“This approval adds to the growing recognition of the value of Focused Ultrasound for global healthcare systems,” commented Maurice R. Ferré MD, Insightec CEO and Chairman of the Board of Directors. “More importantly, expanded access to our technology is helping to transform the lives of people living with debilitating medical conditions.”
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Essential Tremor is a neurological condition that causes uncontrollable shaking in an estimated 41 million people worldwide. More than 80 medical centers around the globe are treating Essential Tremor patients with the Exablate Neuro on a regular basis. Performed in a single session in an MRI suite, many patients experience immediate tremor relief in the treated hand with minimal side effects.
“This technology offers appropriate patients immediate tremor control with a less invasive procedure that requires no incisions or anesthesia with minimal complications,” said Prof. Paresh Doshi, Director of Neurosurgery at Jaslok Hospital and Research Centre and Group Advisor Functional Neurosurgery, Apollo Group of Hospitals, President of The Neuromodulation Society of India and Past President of the Indian Society for Stereotactic and Functional Neurosurgery. “Global clinical studies have demonstrated the procedure as approved is safe and helps patients to regain daily function.”
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