AIIMS-Led Trial Confirms Safety, Effectiveness Of Indigenous Stroke Stent

In a major advance for India’s stroke-care ecosystem, a clinical trial led by the All India Institute of Medical Sciences (AIIMS), Delhi, has confirmed that an indigenously developed brain stent ‘Supernova stent retriever’ is both safe and effective in treating severe strokes. The findings offer fresh hope for expanding access to life-saving stroke treatment in a country like India where cost and infrastructure remain major barriers.

The trial, called GRASSROOT, evaluated the Supernova stent retriever—an advanced device used during mechanical thrombectomy, a procedure that removes blood clots blocking major brain arteries. Importantly, this is the first time a stroke device developed in India has been clinically tested, validated and approved using entirely domestic data. AIIMS Delhi served as the national coordinating centre and the lead enrolling site.

Calling the results a turning point, Dr. Shailesh B. Gaikwad, Professor and Head of Neuroimaging and Interventional Neuroradiology at AIIMS Delhi and National Principal Investigator of the trial, said the device demonstrated strong outcomes in patients with life-threatening strokes. Preliminary findings have been published in the Journal of Neurointerventional Surgery.

The prospective, multicentre study was conducted across eight hospitals in India and focused on patients with large vessel occlusion strokes—among the most severe forms of stroke, where rapid intervention is crucial to prevent death or long-term disability. The results showed a high rate of successful restoration of blood flow, low rates of brain haemorrhage (3.1 per cent) and mortality (9.4 per cent), and functional independence in about half of the patients within 90 days, as per the study ‘Mechanical thrombectomy for acute ischemic stroke in a low- and middle-income country: primary outcomes from the GRASSROOT Trial.’

Based on this evidence, the Central Drugs Standard Control Organisation (CDSCO) approved the Supernova stent retriever for routine clinical use earlier this year, making it India’s first stroke device to receive regulatory clearance following a fully home-grown clinical trial.

Developed by Gravity Medical Technology, the Supernova stent has been designed with India’s stroke burden in mind. Unlike Western countries, strokes in India often occur at a younger age and in settings where access to advanced care is limited. The device has already been used in more than 300 patients across Southeast Asia.

“With manufacturing now shifting to India, the stent will be available at a more affordable cost,” said Dr. Dileep Yavagal, Professor of Neurology and Neurosurgery at the University of Miami, who has been associated with the global evaluation of the device. He noted that this could significantly improve access for India’s estimated 1.7 million stroke patients each year.

Apart from AIIMS Delhi, the GRASSROOT clinical trial was conducted at several leading centres across the country, including Marengo CIMS Hospital, Ahmedabad, Calcutta Medical Research Centre, Kolkata, Apollo Hospitals, Jubilee Hills, Hyderabad, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, Hinduja Hospital and Medical Research Centre and Balabhai Nanavati Hospital in Mumbai, and Yashoda Hospitals, Somajiguda, Hyderabad.

The significance of the GRASSROOT trial extends beyond one device. Mechanical thrombectomy has revolutionised stroke treatment worldwide, but access remains severely restricted in low- and middle-income countries due to the high cost of imported devices, often priced between USD4,000 and USD5,000 per procedure. For many patients, because of the huge costs, timely treatment is unaffordable, noted the authors of the study.

India also faces systemic challenges, including a shortage of thrombectomy-capable centres and limited insurance coverage for emergency stroke care. These constraints have resulted in only a small fraction of eligible patients receiving this life-saving procedure.

By demonstrating that a cost-conscious, high-performance stroke device can be developed, tested and approved within the country, the GRASSROOT trial offers a practical pathway to closing this gap. Experts say it also reflects India’s growing capacity to conduct complex medical device trials to global standards.

Aligned with the government’s Make-in-India initiative, the success of the Supernova stent strengthens confidence in domestic medical innovation and reduces dependence on expensive imports. More importantly, it sets the stage for wider access to advanced stroke care—bringing timely treatment within reach for patients who have long been excluded by cost and infrastructure constraints.