Gravity Medical Technology has announced that its Supernova revascularisation device—a stent-based thrombus retrieval device—has received regulatory approval in India.
The approval follows the successful completion of the GRASSROOT India clinical trial, the results of which will be presented later this year at a global conference. The trial was designed to evaluate the safety and efficacy of the Supernova device in large vessel occlusion (LVO) stroke treatment.
“This is more than a regulatory success—it is a turning point,” said Shashvat Desai (HonorHealth, Scottsdale, USA), Gravity’s chief technology officer. “By demonstrating that groundbreaking trials can be designed and completed within India, we are accelerating global access to advanced therapies while ensuring equity in stroke care.”
“What makes this trial truly significant is not just the device approval, but the infrastructure it has built,” added Ashutosh Jadhav (Barrow Neurological Institute, Phoenix, USA), the company’s chief scientific officer. “India now has a proven framework for running large-scale, high-quality neurointerventional trials—a foundation that will support future innovations in healthcare research.”
Gravity’s mission is to provide sustainable, reliable and affordable access to advanced stroke treatment worldwide. At the heart of this effort is Supernova, which has been engineered to deliver premium performance at a fraction of the cost of traditional stent retrievers, according to the company. The device has been used to treat a number of stroke patients in Pakistan and Thailand within the context of clinical trials as well.
“The GRASSROOT trial is a landmark in India’s stroke care journey,” commented global principal investigator (PI) Dileep Yavagal (University of Miami, Coral Gables, USA). “For the first time, we have generated world-class clinical evidence entirely within India to support the approval of a novel thrombectomy device. This achievement reflects the extraordinary commitment of our investigators and patients across the nation.”
The GRASSROOT trial was initially launched on 15 August 2024—India’s independence day—with the first enrolled patient being successfully treated by India PI Shailesh Gaikwad and his colleague Deepti Vibha at the All India Institute of Medical Sciences (AIIMS) in New Delhi, India.
“Behind every datapoint are real patients and families who placed their trust in this trial,” said Gaikwad. “Their courage and participation will open the doors to faster, more affordable treatment for countless others across India and beyond.”
