The registry will be conducted for approximately two and a half years and up to 200 subjects will be enrolled
MUMBAI, India – 29 March 2022 – India Medtronic Private Limited, a wholly owned subsidiary of Medtronic plc (NYSE:MDT) — a global leader in healthcare technology, today announced the launch of India’s first ever dedicated registry for the collection of real-world data associated with the use of revascularization 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 revascularization 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.
In India, nearly 1.18 million patients are affected by stroke each year of which 68-80% of the strokes are ischemic (i.e., blood clot in the brain).1,2 Although current clinical practice guidelines recommend the use of neurothrombectomy for stroke management, patient utilization remains low in India. In India, while more than 2.7 lakhs patients are eligible for neurothrombectomy each year, fewer than 1500 (~0.5%) are treated with neurothrombectomy.3 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.
Commenting on Medtronic’s disruptive efforts to sharpen clinical understanding of neurothrombectomy in AIS patients, 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.”
Dr. Vipul Gupta, neurointerventionist, Artemis Hospitals, Gurgaon, said, “While the treatment for stroke requires timely intervention before all else, the benefits of thrombectomy care in preventing morbidity is noteworthy. Stroke thrombectomy is minimally invasive, safe, and highly effective. Yet, its potential remains severely underutilized, and it is imperative to foster research and awareness around its benefits. I’m hopeful that the registry initiated by Medtronic will provide us robust data around effectiveness of mechanical thrombectomy in Indian patients.”
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.
Mechanical thrombectomy with the use of stent retrievers has consistently shown improved neurological outcomes and reduced disability within 6 hours post stroke onset.4 Timely removal of blood clot via either neurothrombectomy devices, or clot-dissolving agent to restore the blood flow in brain is essential.5 Six landmark studies have reported reduced disability with the use of mechanical thrombectomy and clot-dissolving agent in patients with AIS.6-11 These outcomes resulted in the new 2015 American Heart Association (AHA/ASA) guidelines with an added recommendation for endovascular treatment with stent retrievers in subjects with large vessel occlusion (LVO).12
About Mechanical Thrombectomy
Based upon current clinical data and usage of these products, the risks associated with the Solitaire™ Revascularization Device and React™ Aspiration Catheter are outweighed by their individual and collective clinical benefits when used as intended in the target population.
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