New Delhi 

AIIMS Delhi has made history in stroke care with India's first dedicated clinical trial of the advanced Supernova Stent, a brain stent designed for treating severe strokes.

The GRASSROOT Trial results, published in the Journal of NeuroInterventional Surgery (JNIS), a publication of the prestigious British Medical Journal group, demonstrate excellent safety and efficacy.

AIIMS New Delhi was the national coordinating centre and the lead enrolling site for the GRASSROOT Trial, India's first clinical trial of a new and advanced stroke treatment device, 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 New Delhi and National Principal Investigator of the GRASSROOT Trial.

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. This is the nation's first stroke device cleared based on a domestic clinical trial.

The approval follows the GRASSROOT India trial, which confirmed the device's safety and efficacy in treating life-threatening strokes. 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.

Noting that it produced world-class clinical evidence entirely within the country, Dr Ashutosh Jadhav (Chief Scientific Officer, Gravity) added that the effort built a "robust framework for future large-scale, high-quality trials." At the same time, Dr. Deepti Vibha (Professor of Neurology, AIIMS, New Delhi) emphasised the role of patients and families whose participation will "bring faster, more affordable treatments to millions."

Dr Shashvat M. Desai, Chief Technology Officer at Gravity Medical Technology, described the approval as "more than just a regulatory milestone." He remarked, "This achievement demonstrates that India can design and deliver clinical trials of global significance, accelerating access to advanced therapies while upholding equity."

He further noted that the trial and subsequent device approval stand as a testament to the expertise of Indian leaders such as Dr Gaikwad and his team, who bring over three decades of experience in advancing stroke treatment.

Dr Gaikwad thanked the entire team involved in this trial, with significant contributions from Dr Manjari Tripathi, Dr Rohit Bhatia, Dr Achal Srivastava, Dr Vishnu, Dr Awadh K Pandit, Dr Rajesh Singh, Dr Ayush Agrawal & Dr Savyasachi Jain (AIIMS team members).

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Developed by Gravity Medical Technology, Supernova is designed for India's diverse patient population, where strokes often occur at younger ages than in the West.

"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" concluded Dr Dileep Yavagal, Professor of Neurology and Neurosurgery, University of Miami, and the Global Principal Investigator of the GRASSROOT Trial.