Medtronic launches clinical registry to assess role of brain blood clot retrieving devices in stroke patients

The registry will be conducted for approximately two and a half years and up to 200 subjects will be enrolled

Medtronic has announced the launch of registry for the collection of real-world data associated with the use of revascularisation devices in acute ischemic stroke (AIS) patients. The Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated with Neurothrombectomy Devices in India (PRAAN) is an industry-first endeavour to create a post-market registry to assess clinical outcomes associated with the use of medtronic market-released revascularisation devices in patients experiencing acute ischemic stroke. The duration of the registry will be approximately 28 months and up to 200 subjects will be enrolled in it. Devices that are used to restore blood flow in the brain by mechanically removing blood clots from occluded blood vessels are called neurothrombectomy (or mechanical thrombectomy) devices, which include stent retrievers and aspiration catheters.

Data emerging from prospective studies can provide information on patient characteristics, systems of care and the (short-term) clinical outcomes of neurothrombectomy on Indian patients. These data may provide valuable insights that will facilitate greater awareness of this therapy, improve care delivery systems and enable policy decisions to provide access to treatments.

Madan Krishnan, Vice President and Managing Director, Medtronic India said, “Medtronic remains firmly committed to the practice of evidence based medicine in the medical device industry in India. Facilitating patient access to life-saving therapies requires world-class clinical and economic outcomes evidence. The kickstart of PRAAN registry marks the beginning of one of many pioneering efforts undertaken by the company in stroke management. We hope to gain valuable insights from the emerging data from our prospective registry.”

Dr Jeyaraj Pandian, Vice President, World Stroke Organization and President, Indian Stroke Association, said, “Stroke is one of the leading causes of death and disability in India, and there exists a pressing need to deepen our understanding of stroke patients and prospective therapies and treatments. Medtronic’s PRAAN registry can play a critical first step in the creation of a comprehensive database for stroke patients in India, taking us closer to bringing beneficent therapy systems and policy interventions for their care.”

Subject enrolment for PRAAN is already underway, with 18 months of a scheduled enrolment window until February 2023. Publication of the reports of the registry is expected to happen in December 2023.