: Saturday, December 13, 2025 11:53 PM
New Delhi. All India Institute of Medical Sciences (AIIMS) played the role of the national coordination center and main enrolling site in the grassroots clinical trial of India’s first advanced stroke treatment device, the Supernova Stent. Dr. Shailesh B., professor in the department of neuroimaging and interventional neuroradiology at AIIMS and national principal investigator of the trial. Gaikwad said that this trial is a new milestone for stroke treatment in India. The results of the grassroots trial have been published in the prestigious Journal of Neurointerventional Surgery (JNIS), which is part of the British Medical Journal Group. The publication reported that the use of the Supernova stent (Gravity Medical Technology) has shown excellent results in the safety and efficacy of treatment in severe stroke patients. Earlier this year, data from the grassroots trial was accepted by the Central Drugs Standard Control Organization (CDSCO) and the Supernova stent-retriever was approved for routine use in India. This is India’s first stroke device to be approved based on indigenous clinical trials. This approval has given a major push to the Make-in-India initiative and has positioned India at the global level in advanced stroke care.
Dr. Ashutosh Jadhav, Chief Scientific Officer of Gravity, said that this trial has laid a strong foundation for future larger and higher quality trials. Dr. Deepti Viva, Neurology Professor, AIIMS, called the participation of patients and their families important, so that fast and affordable treatment can reach millions.
Dr. Shashwat M. Desai, Chief Technology Officer, Gravity, called this not just a regulatory approval but a major historic step. He said this shows that India can conduct global-scale clinical trials and ensure faster access to advanced therapies.
Dr. Gaikwad also thanked the team involved in the entire trial. This includes Dr. Manjari Tripathi, Dr. Rohit Bhatia, Dr. Achal Srivastava, Dr. Vishnu, Dr. Awadh Pandit, Dr. Rajesh Singh, Dr. Ayush Aggarwal and Dr. Savyasachi Jain from the AIIMS team.
The Supernova Stent developed by Gravity Medical Technologies has been specifically designed for the diverse population of India, where stroke typically occurs at a younger age than in western countries.
Dr. Dilip Yavagal, University of Miami professor and global principal investigator of the grassroots trial, said the device has already treated more than 300 patients in Southeast Asia. Now it will be made in India and will be available at an affordable price. This will bring new hope to the 1.7 million Indians who suffer from stroke every year.
This trial and approval of the device is a major step towards safety, effectiveness and cost-effective treatment of stroke in India. This proves that India is now becoming a leader not only in treatment but also in global level medical research and innovation.
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Web Title-AIIMS Creates History in Stroke Care: First Clinical Trial for the Most Advanced Brain Stent Successful
