India’s first indigenously developed Supernova stent retriever for severe stroke treatment has been approved for manufacture and sale. The Central Drugs Standard Control Organisation (CDSCO) cleared the device after clinical trials done entirely in India showed strong safety and effectiveness. Developed by Gravity Medical Technology, the device removes blood clots, restoring brain blood flow within 24 hours. The trial, known as the GRASSROOT trial, was led by AIIMS Delhi as the national coordination center and top enrolling site. Shailesh B. Gaikwad, head of AIIMS’s Department of Neuroimaging & Interventional Neuroradiology and National Principal Investigator of the trial, said, "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." The trial involved eight centers and was the first in India to test a stroke device based solely on domestic data. Results published in the Journal of Neurointerventional Surgery reported high success in restoring blood flow, with just 3.1% brain bleed cases and 9.4% mortality. Half the patients regained functional independence within 90 days. The device has already helped over 300 patients in Southeast Asia and will now be made in India for local patients. With 1.7 million Indians suffering strokes yearly, the affordable Supernova stent aims to bring hope and better outcomes. Dileep Yavagal, professor at the University of Miami, praised the device’s growing impact and regional use. Shashvat M Desai, CTO of Gravity Medical Technology, highlighted that, "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." Manufacturing is expected to start soon, with a launch planned for February 2026.