Indian Ministry of Health and Family Welfare Approves Exablate Neuro-Focused Ultrasound Platform
HAIFA, Israel and MIAMI, Florida, September 20, 2021 / PRNewswire / – Insightec®, a global healthcare company focused on transforming patient care, announced its incisionless neurosurgery platform, Exablate® 4000, has received marketing approval from the Central Drugs Standard Control Organization (CDSCO), part of the Department of Health and Family Welfare of India.
The Exablate 4000 (Exablate Neuro) platform uses MRI-guided focused ultrasound to accurately ablate a small target deep in the brain without incisions. The approval will allow the 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 health systems,” commented Maurice R. Ferré MD, CEO of Insightec and Chairman of the Board. “Most importantly, expanded access to our technology is helping transform the lives of people with debilitating medical conditions.
Essential tremor is a neurological disease that causes uncontrollable tremors in approximately 41 million people worldwide. More than 80 medical centers around the world regularly treat patients with essential tremor with Exablate Neuro. Performed in one session in an MRI room, many patients experience immediate relief from the tremor in the treated hand with minimal side effects.
“This technology provides appropriate patients with 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 Center and Group Advisor in Functional Neurosurgery, Apollo Group of Hospitals, President of the Neuromodulation Society of India and former president of the Indian Society for Stereotaxic and Functional Neurosurgery. “Global clinical studies have shown that the approved procedure is safe and helps patients regain their daily functions.”
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 for patients with drug-resistant essential tremors and tremor-dominant Parkinson’s disease. Research for future applications in the field of neuroscience is underway in partnership with leading academic and medical institutions. Insightec is headquartered at Haifa, Israel, and Miami, with offices in Dallas, Shanghai and Tokyo.
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