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