In a move that paves the way for faster and more affordable care for millions of stroke patients in India, the Central Drugs Standard Control Organisation (CDSCO) has given approval to market the Supernova stent retriever — which can clear blood clots from blocked arteries and restore blood flow within 24 hours.
The All India Institute of Medical Sciences (AIIMS), Delhi, successfully conducted a trial of the stent, and preparations are ongoing for its manufacturing in India.
Currently, an imported version is available across major cities. The first ‘Made in India’ stents will become available in February, said Dr Shailesh B Gaikwad, Professor and Head of the Department of Neuroimaging and Interventional Neuroradiology at AIIMS.
What is a Supernova stent?
The Supernova stent-retriever is an advanced device designed to treat severe, life-threatening strokes. In simple terms, it is an upgraded clot-retrieval device that can remove multiple types of blood clots, more effectively open blocked arteries, and significantly improve outcomes for stroke patients.
AIIMS, Delhi, had served as the national coordinating centre and the lead enrolling site for the GRASSROOT Trial, India’s first clinical evaluation of the Supernova stent-retriever.
Dr Gaikwad said the trial was to see that the device is safe for Indian patients. “So that aspect has been successful. The second objective was to get it imported and set up a manufacturing unit here in India under the ‘Make in India’ initiative. CDSCO has given the approval to manufacture it in India and preferably by February, the work will begin,” he said.
Why is this significant?
For years, stroke patients in the West have been able to prevent severe brain damage through the use of sophisticated retriever stents. In India, however, this life-saving technology has remained largely out of reach — even as the incidence of brain strokes continues to rise — mainly due to its high cost.
That gap may now be narrowing.
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Developed with India’s diverse patient population in mind where strokes often affect younger individuals compared to Western countries, the Supernova stent will now be manufactured and made available in India at affordable prices.
The new device is expected to cost nearly one-fourth of the currently available imported versions, potentially making advanced stroke care accessible to a much larger section of the Indian population.
It has already been used to treat more than 300 patients across Southeast Asia.
How does it work?
A stent-retriever is a thin, cylindrical mesh tube that is inserted through a catheter and expanded within the artery to widen the vessel walls. Once the clot gets trapped in the stent’s mesh, it is pulled out by the catheter. It doesn’t need permanent deployment. The removal can be done within 10 minutes and the blood flow to the brain can be restored rapidly.
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“The new stent-retriever has been designed specifically to tackle the unique features of a stroke clot in the Indian population, given that our arteries are narrower. The new device was first used on August 25. The patient is doing well,” said Dr Gaikwad.
The AIIMS trial
The trial was led by Dr Gaikwad, who was also the National Principal Investigator of the study. “This trial is a turning point for stroke treatment in India,” said Dr Gaikwad, highlighting the significance of generating high-quality clinical evidence within the country.
The results have been published in the Journal of Neurointerventional Surgery (JNIS), a leading international journal under the British Medical Journal (BMJ) group. According to the publication, the Supernova stent, developed by Gravity Medical Technology, demonstrated excellent safety and efficacy outcomes in patients suffering from severe strokes.
Earlier this year, the trial data was accepted by CDSCO, leading to regulatory approval of the Supernova stent-retriever for routine clinical use in India. Notably, this marks the first time a stroke treatment device has been approved in the country based solely on data from a domestic clinical trial.
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Conducted across eight centres nationwide, the GRASSROOT Trial is being seen as a major boost to the government’s Make-in-India initiative, positioning India as a global contributor to advanced stroke care and clinical research.
What do doctors say?
Dr Ashutosh Jadhav, Chief Scientific Officer at Gravity Medical Technology, said the trial established a “robust framework for future large-scale, high-quality clinical trials” in India.
Dr Deepti Vibha, Professor of Neurology at AIIMS, emphasised the role of patients and their families, noting that their participation would help “bring faster, more affordable treatments to millions.”
Calling the approval “more than just a regulatory milestone,” Dr Shashvat Desai, Chief Technology Officer at Gravity Medical Technology, said the achievement demonstrates India’s ability to design and execute clinical trials of global relevance. “It accelerates access to advanced therapies while upholding equity,” he said.
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“This offers new hope to the nearly 1.7 million Indians who suffer strokes each year,” said Dr Dileep Yavagal, Professor of Neurology and Neurosurgery at the University of Miami and Global Principal Investigator of the GRASSROOT Trial.
