One-year data from the SMART study demonstrates that the Medtronic Evolut™ TAVR platform is the optimal treatment for severe aortic stenosis in patients with small annulus, who are primarily women

New data from the largest head-to-head TAVR randomized control trial demonstrates non-inferior clinical outcomes and superior valve performance for Evolut TAVR compared to Sapien™ at one year

DUBLIN AND ATLANTA, April 7, 2024 /PRNewswire/ — Medtronic plc (NYSE: NYSE:), a global leader in healthcare technology, today announced that new data from the largest head-to-head comparative study of transfemoral transcatheter aortic valve replacement (TAVR) was submitted as a late-breaking clinical trial at American college of Cardiology annual Scientific session and simultaneously published in The New England Journal of Medicine. One year results SMAll Athe answer Randomized To The Evolut o SAPIEN (SMART) study in subjects with aortic stenosis (AS) with small aortic annulus (SAA) demonstrated non-inferior clinical outcomes and superior valve performance as measured by bioprosthetic valve dysfunction performance for the platform Evolut™ TAVR compared to the SAPIEN™ platform.

“SMART was launched to better understand how the two most commonly used TAVR systems work in patients with small aortic rings and particularly in women who tend to have smaller heart valves,” he said Nina Buoncuore, senior vice president and president of Structural Heart & Aortic, which is part of Medtronic’s cardiovascular portfolio. “We continue to develop evidence to better understand the benefits of our Evolut TAVR technology in all patients, including patient populations that are underrepresented, underdiagnosed and undertreated. The results of the SMART study demonstrate these benefits in a broad patient population and strengthen our commitment to advancing health equity and designing the best technology to solve patients’ unmet needs.”

In addition to being the largest comparative TAVR study, SMART is also the largest TAVR study to date enrolling primarily women (87%). Symptomatic severe aortic stenosis can be fatal if left untreated, and the average patient survival is two years without treatment.¹ Despite women’s longer life expectancy, once affected by severe aortic stenosis they suffer a higher mortality rate than men, even after the same age.² Both TAVR and surgical aortic valve replacement (SAVR) are options for treating AS for women. Because of their smaller aortic rings, women may often receive a valve replacement that does not adequately fit their anatomy,” highlighting the need for clinical trials to guide the best treatment approaches.³ Additionally, despite the prevalence of chronic conditions associated with AS in women over 65, a new survey of more than 1,000 women announced today found that most have never been referred to a cardiologist.

“As clinicians, we know that tailored approaches are needed to address the unique presentation of AS in the small annulus patient population, which is primarily made up of women. There is little comparative data to help us with valve selection,” he said Howard C. HermannMD, Perelman School of Medicine to the University of Pennsylvania, Philadelphia, Pennsylvania.and lead investigator of the SMART study. “While we know that women experience a greater benefit than men when treated with TAVR versus SAVR, now for the first time there is definitive data demonstrating that women have the best valve performance when treated with the Evolut TAVR system.”

The SMART Trial is an international, prospective, multicenter, randomized (1:1) postmarket study comparing the safety and performance of self-expandable versus balloon-expandable TAVR in patients with severe symptomatic AS and SAA. The study randomized and treated 716 patients, 87% of whom were women, at more than 80 centers worldwide. Eligible patients had computed tomography aortic valve annulus area of ​​‰¤430 mm² and anatomy suitable for transfemoral TAVR with either an Evolut PRO/PRO+/FX valve or a SAPIEN 3™/3 Ultra™ valve.

“For patients undergoing heart valve replacement, early dysfunction of the bioprosthetic valve may result in an increased risk of serious long-term outcomes, including mortality and rehospitalization,” he added Doctor Herrmann. “As physicians, this data further reinforces that not all valves are created equal and we must absolutely consider valve performance when determining device choice.”

The results demonstrated that the Evolut TAVR platform met both co-primary endpoints of clinical non-inferiority and hemodynamic superiority at one year.

• Evolut TAVR achieved non-inferiority for the primary clinical outcome endpoint, a composite of all-cause mortality, disabling stroke, or heart failure rehospitalization at one year (9.4% Evolut vs. 10.6% SAPIEN, p
• Evolut TAVR demonstrated superiority for the primary endpoint of valve function, bioprosthetic valve dysfunction over one year (9.4% Evolut vs. 41.6% SAPIEN, p

“Medtronic is committed to providing doctors and patients with long-term data on aortic stenosis to help guide their treatment decisions,” he said Jeffrey Popma, MD, vice president and medical director for the Coronary and Renal Denervation businesses and the Structural Heart and Aortic businesses at Medtronic. “Our previous studies have shown an important link between valve performance, mortality and rehospitalization at five years. All SMART patients will be followed for five years to evaluate the relationship between better valve performance and better clinical outcomes in patients with annular small size.”

Briefing for analysts and investors

Medtronic will host a briefing for analysts and investors to discuss the results of the SMART trial on Sunday, April 7, 2024 at 10:45 a.m. EDT. The briefing will feature remarks from Medtronic management, immediately followed by responses to questions from institutional investors and equity analysts. A listen-only live webcast will be available, which can be accessed by clicking on the Events link at investorrelations.medtronic.com on April 7. An archived replica will be available on the same web page later in the day. This event is not part of the ACC’s official scientific sessions.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plcbased in Dublin, Ireland, is the world’s leading health technology company that boldly tackles the most challenging health problems facing humanity by researching and finding solutions. Our mission to “relieve pain, restore health and prolong life” unites a global team of more than 95,000 passionate people in 150 countries. Our technologies and therapies treat 70 conditions and include cardiac devices, surgical robotics, insulin pumps, surgical instruments, patient monitoring systems and more. Fueled by our diverse knowledge, our insatiable curiosity and desire to help everyone in need, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we power insights-driven care, people-first experiences, and better outcomes for our world. In everything we do, we design the extraordinary. For more information about Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn.

All forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with 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 (NYSE:).

¹Carabello BA, Paulus WJ. Aortic stenosis. Hand. March 14, 2009;373(9667):956-966.

²I’m Heart Assoc, 2021;10:e018816. DOI: 10.1161/JAHA.120.018816.

³Lester 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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