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Medtronic reveals new women-only data on groundbreaking head-to-head SMART trial

ATLANTA and DUBLIN, May 20, 2024 /PRNewswire/ -- Medtronic, the global leader in healthcare technology, today announced new data from the largest head-to-head comparative trial of transfemoral transcatheter aortic valve replacement (TAVR), the SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial, looking exclusively at women. The findings showed the Evolut self-expanding valve (SEV) was associated with significantly less bioprosthetic valve dysfunction (BVD) and improved quality of life for women with symptomatic severe aortic stenosis (AS). The data was presented as a late-breaking trial at the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2024.

Symptomatic severe AS can be fatal if left untreated and the average patient survival is two years without treatment.¹ Despite women's longer life expectancy, once impacted by severe AS they suffer from higher mortality than men, even after matching for age.² Both TAVR and surgical aortic valve replacement (SAVR) are options for women to treat AS. However, due to their smaller aortic annuli, women can often receive a valve replacement that does not properly fit their anatomy.³

Results demonstrated the primary clinical endpoint for composite of death, disabling stroke, or heart failure rehospitalization was similar amongst women with AS and small annulus randomized to balloon-expandable valve (BEV) or SEV at one year. However, , compared to a balloon-expandable valve, the Evolut SEV was associated with significantly less BVD (8.4% vs. 41.8% at 12 months), less prosthesis-patient mismatch (11.1% vs. 37.4% at 12 months), less mild or greater total aortic regurgitation (12.3% vs. 18.8% at 12 months), and improved quality of life in women with AS and small annulus. 

"This study is a major milestone for women, who have historically been excluded and underrepresented in clinical trials," said Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, MSCAI, Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials, Mount Sinai School of Medicine and co-lead investigator of the SMART Trial. "This subset of the data reinforces that compared to balloon-expandable valves, the Evolut TAVR system was associated with significantly less bioprosthetic valve dysfunction and improved quality of life in women."

The SMART trial is the largest TAVR trial to date to enroll primarily women (87%) and was designed to better understand how the two most commonly used TAVR systems perform in patients with small aortic annuli (SAA) which typically are women. SMART is an international, prospective, multi-center, randomized (1:1) post-market trial comparing the safety and performance of SEV versus BEV TAVR in patients with symptomatic severe AS and SAA. The trial randomized and treated 637 women across more than 80 sites worldwide. Eligible patients had a computed tomography aortic valve annulus area of ≤430 mm² and suitable anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a SAPIEN 3™/3 Ultra™ valve.

"The data presented today at EuroPCR provides meaningful insights into the benefits Evolut TAVR has for women," said Matt Leafstedt, Vice President Structural Heart Western Europe, which is part of the Cardiovascular Portfolio at Medtronic. "This new analysis reinforces TAVR's effectiveness as a solution for achieving superior valve performance while also highlighting the importance of clinical evidence to inform the best treatment approaches for women."

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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 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 (NYSE: MDT), 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.

SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation.

¹ Carabello BA, Paulus WJ. Aortic stenosis. Lancet. March 14, 2009;373(9667):956-966.
² Tribouilloy C, Bohbot Y, Rusinaru D, et al. J Am Heart Assoc. 2021;10:e018816. DOI: 10.1161/JAHA.120.018816.
³ Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The natural history and rate of progression of aortic stenosis. Chest. April 1998;113(4):1109-1114

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