Insightec has 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.
The Exablate 4000 (Exablate Neuro) platform uses magnetic resonance imaging (MRI)-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.
Essential tremor is a neurological condition that causes uncontrollable shaking in an estimated 41 million people worldwide, according to an Insightec press release. More than 80 medical centres around the globe are treating essential tremor patients with the Exablate Neuro on a regular basis. Performed during a single session in an MRI suite, many patients experience immediate tremor relief in the treated hand with minimal side-effects, the release adds.
“This technology offers appropriate patients immediate tremor control with a less invasive procedure that requires no incisions or anaesthesia with minimal complications,” said Paresh Doshi, director of neurosurgery at Jaslok Hospital and Research Centre (Mumbai, India), group advisor of functional neurosurgery at the 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.”
“This approval adds to the growing recognition of the value of focused ultrasound for global healthcare systems,” added Maurice R Ferré, 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.”