New Delhi, Dec 13 The Supernova Stent -- a new and advanced brain treatment device -- has been demonstrated to be safe and effective for stroke patients, said experts at AIIMS Delhi on Saturday, who led the first clinical trial.
AIIMS Delhi was the national coordinating centre and the lead enrolling site of the GRASSROOT trial for the Supernova Stent.
“This trial is a turning point for stroke treatment in India,” said Dr. Shailesh B. Gaikwad, Professor & Head, Department of Neuroimaging & Interventional Neuroradiology, AIIMS Delhi, and National Principal Investigator of the GRASSROOT Trial.
“The Supernova stent has shown excellent safety and efficacy outcomes in the treatment of severe strokes, according to the preliminary trial results,” revealed the preliminary findings published in the reputed Journal of Neurointerventional Surgery (JNIS).
In the first prospective multicentre thrombectomy (procedure to physically remove a blood clot from a blocked artery) trial, the Supernova stent retriever achieved high successful restoration of blood flow with brain bleed (3.1 per cent), mortality (9.4 per cent), and 50 per cent functional independence at 90 days.
Developed by Gravity Medical Technology, Supernova is designed for India’s diverse patient population, where strokes often strike patients younger than in the West.
Earlier this year, data from the GRASSROOT trial were accepted by the Central Drugs Standard Control Organisation (CDSCO), and the Supernova stent-retriever was approved for routine use in India.
The GRASSROOT India trial, which confirmed the device’s safety and efficacy in treating life-threatening strokes, was conducted across eight centres. The trial marks a milestone for the Make-in-India initiative and positions India as a global player in advanced stroke care, the experts said.
“The device has already treated more than 300 patients in Southeast Asia and will now be manufactured and is available in India at affordable prices, offering new hope to the 1.7 million Indians who suffer strokes each year,” said Dr Dileep Yavagal, Professor of Neurology and Neurosurgery, University of Miami, part of the global trial.
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