-First dedicated industry sponsored registry on the use of mechanical thrombectomy devices in patients for acute ischemic stroke (AIS) resulting in great functional and performance outcomes with low mortality rate
-These results corroborate the evidence that Mechanical Thrombectomy is safe and effective treatment for AIS in Indian Population
Medtronic, a global leader in healthcare technology, unveiled results from the Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated with stroke Devices in India (PRAAN) at the World Stroke Congress 2024, held in Abu Dhabi. PRAAN is India’s first industry-sponsored dedicated registry on mechanical thrombectomy, collecting real-world data on the use of stroke devices in patients with acute ischemic stroke (AIS) caused by large vessel occlusion.
The multi-centre study evaluates the clinical outcomes associated with market-released stroke devices of Medtronic for AIS patients with large vessel occlusion condition. The PRAAN registry enrolled 200 patients over 24 months, across 14 centers, and demonstrated that mechanical thrombectomy is a safe, effective, as well as cost-effective treatment for AIS in India.
In India, approximately 1.18 million patients experience stroke annually, with around 21% being suitable for mechanical thrombectomy procedures. Mechanical thrombectomy is a minimally invasive surgery to remove the brain clot. The current adoption rate of mechanical thrombectomy is less than 0.1% in India, generally owing to lack of awareness and access. The PRAAN study aims to bridge this gap by providing real-world data to healthcare professionals and policy makers, thus enabling them to strengthen stroke management in India by improving accessibility and adoption.
The data from the PRAAN study demonstrated high rates of positive functional outcomes and procedural success of mechanical thrombectomy with a low mortality rate in AIS patients. Additionally, the health economic analysis revealed that mechanical thrombectomy (MT) alone or in combination with intravenous tissue plasminogen activator (IV-tPA) appears to be cost-effective compared to IV-tPA treatment alone.
Highlights of the outcomes from the PRAAN Study
· The results from the study are comparable to the global clinical registries and randomized clinical trials.
· The success rate of revascularization, which means clearing a blood clot and getting blood flowing again in the vessel, is 87.4% after the final attempt.
· After 90 days following the procedure, 65.8% of the patients had little or no disability.
· MT treatment is cost-effective as it helps people live better lives following a stroke. Patients treated with MT improved more after 90 days than those who only got IV-tPA treatment
Discussing the PRAAN registry, Mandeep Singh Kumar, Vice President and Managing Director, Medtronic India, said, “Stroke is the fourth leading cause of death in India, making it one of the top non-communicable diseases in the country. Medtronic is committed to advancing innovative and effective treatments for stroke, aiming to enhance patient outcomes as part of its mission to alleviate pain, restore health, and extend life. PRAAN is a first-of-its kind multi-centric prospective stroke clinical registry in India that tracks and reports on mechanical thrombectomy. We are confident that the data and outcomes from the study will help ignite critical discourse to raise awareness about the dangers of stroke and available treatment pathways and will empower healthcare professionals and policy makers alike in providing the right resources and guidance for the Indian public.”
Dr. Mathew Cherian, HOD Intervention Radiology at KMCH, Coimbatore, said, “A cerebral infarction caused by a blockage in the brain’s blood vessels can result in permanent disability or death. However, thanks to mechanical thrombectomy, patients now have a treatment option available that can enable them to regain their mobility and resume their day-to-day activities. A recent multi-center trial conducted in India by Medtronic has once again proven the remarkable effectiveness of this groundbreaking stroke treatment in India.”
Dr. Vikram Huded, Director and Clinical Lead, Interventional Neurology Programme of NH group, Head of Neurology, Narayana Health, Bengaluru, commented,” Stroke is a medical emergency impacting millions of lives. Mechanical thrombectomy is a revolutionary treatment that has increased the treatment window up to 24 hours since the onset of symptoms in stroke. However, it is important to assess the impact of the procedure with the Indian patient pool and for that Medtronic has conducted the PRAAN study in India. The study has demonstrated good clinical outcomes like 65.8% had mRS score between 0-2 at 90 days follow-up which provides us the assurance about the efficacy of MT among Indian patients.”
About Medtronic:
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. No statements or comments made in this release may be construed as medical advice and patients need to consult their physicians for the same.
References:
Zaidat, O. O., Fifi, J. T., Nanda, A., Atchie, B., Woodward, K., Doerfler, A., Tomasello, A., Tekle, W., Singh, I. P., Matouk, C., Thalwitzer, J., Jargiełło, T., Skrypnik, D., Beuing, O., Berge, J., Katz, J. M., Biondi, A., Bonovich, D., Sheth, S. A., . . . Richard, P. (2021). Endovascular treatment of acute ischemic stroke with the penumbra system in routine practice: COMPLETE registry results. Stroke, 53(3), 769–778. https://doi.org/10.1161/strokeaha.121.034268
Gupta, R., Miralbés, S., Bonilla, A. C., Naravetla, B., Majjhoo, A. Q., Rayes, M., Spiotta, A. M., Loehr, C., Cioltan, A., Vollherbst, D. F., Martínez-Galdámez, M., Galván-Fernandez, J., Khaldi, A., McTaggart, R. A., Jayaraman, M. V., Defreyne, L., Dhondt, E., Vega, P., Murias, E., . . . Möhlenbruch, M. A. (2024). Technique and impact on first pass effect primary results of the ASSIST global registry. Journal of NeuroInterventional Surgery, jnis-021126. https://doi.org/10.1136/jnis-2023-021126
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