Indigenous Stroke Device Gains Approval with Domestic Trial Data, Launch Scheduled for February 2026

Key Takeaways

The Supernova stent retriever is set to launch in India in February 2026, offering new treatment options for severe strokes.
Approved based on domestic clinical trial data, it is the first stroke device in India to receive such approval.
The device has already proven effective in Southeast Asia, with successful outcomes in treating severe stroke cases.

Breakthrough in Stroke Treatment

The Supernova stent retriever, a groundbreaking device developed by Gravity Medical Technology, represents a significant advancement in the treatment of severe strokes in India, which affects approximately 1.7 million individuals annually. Approved by the Central Drugs Standard Control Organisation (CDSCO), this innovative device will be manufactured in India and is slated for launch in February 2026.

The clinical trial, known as the GRASSROOT trial, was led by the All-India Institute of Medical Sciences (AIIMS) in Delhi. This trial marked a vital milestone as it is the first time a stroke treatment device in India has been approved using solely domestic clinical trial data. Dileep Yavagal, professor of Neurology and Neurosurgery at the University of Miami, emphasizes the significance of the Supernova stent in improving treatment outcomes for stroke patients.

Shailesh B. Gaikwad, a professor at AIIMS and National Principal Investigator of the GRASSROOT trial, noted that the Supernova stent exhibited impressive efficacy and safety in clinical settings. Data from the trial, recently published in the Journal of Neurointerventional Surgery, highlighted the stent’s success in restoring blood flow and its associated low rates of complications.

The trial, conducted across eight centers, demonstrated that the Supernova stent retriever succeeded in restoring blood flow in a high percentage of cases, with a brain bleed rate of only 3.1 percent and a mortality rate of 9.4 percent. Furthermore, 50 percent of patients achieved functional independence within 90 days of the procedure.

The device has been previously employed to treat over 300 patients in Southeast Asia, marking its established safety and versatility in real-world applications. Shashvat M Desai, Chief Technology Officer at Gravity Medical Technology, stated that the approval showcases India’s capability in conducting competitive clinical trials on a global scale and highlights the need for devices suited to the country’s unique health profile, where strokes often affect younger individuals.

The introduction of the Supernova stent retriever not only enhances stroke treatment options in India but also aims to provide affordable care for millions, underscoring the critical advancements in medical technology and patient care.

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