The device offers new hope to the 1.7 million Indians who suffer strokes each year, said Dileep Yavagal, professor of Neurology and Neurosurgery, University of Miami, who was part of the global trial.
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The indigenously developed Supernova stent retriever—approved in India using only domestic clinical trial data— is expected to be manufactured in the country and launched in February 2026. The device is used to treat severe strokes by removing clots and restoring blood flow to the brain within 24 hours.
Developed by Gravity Medical Technology, its clinical trial was led by the All-India Institute of Medical Sciences (AIIMS), Delhi. The Central Drugs Standard Control Organisation (CDSCO) has approved the device’s manufacturing and marketing in India after the trial demonstrated good safety and efficacy outcomes. It is the first time a stroke device has been approved in India based solely on domestic clinical trial data.
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. Supernova stent showed strong performance in real-world clinical settings involving severe stroke cases,” said Shailesh B. Gaikwad, professor and 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 findings published recently in the 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.
The India trial was conducted across eight centres. The device has already been used to treat more than 300 patients in Southeast Asia and will now be manufactured and made available in India at affordable prices, offering new hope to the 1.7 million Indians who suffer strokes each year, added Dileep Yavagal, professor of Neurology and Neurosurgery, University of Miami, who was part of the global trial.
Shashvat M Desai, chief technology officer at Gravity Medical Technology, said the approval reflects India’s ability to conduct globally competitive trials. “The Supernova stent is tailored to India’s unique stroke profile, where strokes tend to occur at a younger age compared to Western populations. The device has already been used to treat patients in Southeast Asia, reinforcing its safety and versatility,’’ he said.
Published – December 20, 2025 07:26 pm IST
