Insightec, a global healthcare firm, has announced that the Exablate 4000, an incisionless neurosurgical platform, has obtained market approval from the Central Drugs Standard Control Organization (CDSCO), which is part of India’s Ministry of Health and Family Welfare.
Without incisions, the Exablate 4000 (Exablate Neuro) technology employs MR-guided focused ultrasound to accurately ablate a tiny target deep within the brain. The clearance would allow patients with Essential Tremor, Tremor-Dominant Parkinson’s Disease, and Neuropathic Pain in India to be treated.
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 thelives of people living with debilitating medical conditions.
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.”
Insightec is a medical technology innovator focused on transforming patient lives through incisionless surgery.