AIIMS Trial Confirms Supernova Stent’s Safety for Stroke Patients

Experts at AIIMS Delhi announced that the Supernova Stent, developed by Gravity Medical Technology, has been confirmed as safe and effective for treating patients who have suffered severe strokes. This significant finding emerged from the GRASSROOT trial, which was led by AIIMS and included multiple centers across India. The trial’s success has important implications for stroke management in the country.

The Supernova Stent, which received approval from the Central Drugs Standard Control Organisation (CDSCO) earlier this year, is set to be manufactured in India at affordable prices. According to Dr. Shailesh B. Gaikwad, Professor and Head of the Department of Neuroimaging & Interventional Neuroradiology at AIIMS Delhi, and the National Principal Investigator of the GRASSROOT Trial, “This trial is a turning point for stroke treatment in India.”

Key Findings from the GRASSROOT Trial

Preliminary results from the GRASSROOT trial revealed that the Supernova Stent achieved a high success rate in restoring blood flow during thrombectomy procedures, with a brain bleed rate of just 3.1 percent and a mortality rate of 9.4 percent. Importantly, the trial reported that 50 percent of patients achieved functional independence within 90 days of the procedure. These outcomes were detailed in findings published in the respected Journal of Neurointerventional Surgery (JNIS).

The GRASSROOT trial marks the first prospective multicenter thrombectomy study to evaluate this innovative device. Conducted across eight centers, the trial not only confirmed the stent’s safety and efficacy but also positions India as a global player in advanced stroke care. Dr. Dileep Yavagal, a Professor of Neurology and Neurosurgery at the University of Miami and part of the global trial, noted, “The device has already treated more than 300 patients in Southeast Asia and will now be manufactured in India, offering new hope to the 1.7 million Indians who suffer strokes each year.”

Impact on India’s Healthcare Landscape

The introduction of the Supernova Stent aligns with India’s Make-in-India initiative, emphasizing local manufacturing and accessibility. As strokes tend to affect younger populations in India compared to Western countries, the device has been tailored to meet the needs of this diverse patient demographic.

Experts believe that the availability of the Supernova Stent at affordable prices will significantly improve treatment options for stroke patients across the country. With this breakthrough, AIIMS Delhi and its partners are optimistic about enhancing patient outcomes and reducing the burden of stroke-related disabilities in India.

In summary, the successful trial and subsequent approval of the Supernova Stent represent a major advancement in stroke treatment, showcasing India’s potential to lead in medical innovation while addressing critical healthcare challenges.