SMART Trial two-year data continues to demonstrate superior valve performance for Evolut TAVR™ system in small annulus patients

Rhea-AI Summary

Medtronic (NYSE: MDT) has released two-year results from the SMART Trial, comparing their Evolut TAVR system with SAPIEN TAVR in patients with small aortic annulus. The study, presented at CRT 2025, is the largest international head-to-head comparative trial primarily enrolling women (87% of 716 patients) across 80+ sites worldwide.

The trial demonstrated comparable outcomes in mortality, disabling stroke, and heart failure hospitalization between both devices. However, Evolut TAVR showed superior valve performance with significantly less bioprosthetic valve dysfunction (BVD). Key findings include five times less prosthetic valve thrombosis and nine times less hemodynamic structural valve dysfunction compared to SAPIEN TAVR.

Positive

• Superior valve performance demonstrated with significantly less bioprosthetic valve dysfunction
• 5x reduction in prosthetic valve thrombosis vs competitor
• 9x reduction in hemodynamic structural valve dysfunction vs competitor

Negative

• No significant difference in composite clinical outcomes (mortality, stroke, heart failure) compared to competitor

Insights

Cardiologist & Medical Device Specialist

The two-year SMART Trial data represents significant positive evidence for Medtronic's Evolut TAVR system in the important small annulus patient segment. The results demonstrate superior valve performance with five times less prosthetic valve thrombosis and nine times less hemodynamic structural valve dysfunction compared to the SAPIEN device.

These findings have substantial clinical implications because valve performance issues are magnified in small annulus patients. While composite clinical outcomes (mortality, stroke, heart failure hospitalization) remain comparable, the superior hemodynamic performance could translate to better long-term outcomes as the data matures.

Notably, this represents the largest head-to-head randomized TAVR trial specifically focusing on small annulus patients, with 87% female enrollment across 80+ international sites. This demographic focus is strategically important as women disproportionately present with small annuli.

The five-year follow-up will be important to determine if these hemodynamic advantages translate into clinical outcome differences. For Medtronic, these results strengthen their competitive position against Edwards Lifesciences in this specific patient segment, potentially driving increased market share in the rapidly growing TAVR market, particularly as treatment expands to younger patients where long-term valve durability becomes increasingly important.

Financial Analyst

The SMART Trial data represents a meaningful competitive advantage for Medtronic in the high-growth TAVR market. With superior valve performance clearly demonstrated in this head-to-head comparison, Medtronic gains significant clinical differentiation against Edwards Lifesciences' SAPIEN platform in the small annulus segment.

This clinical advantage targets a strategic demographic, as small annulus patients (predominantly women) represent a substantial portion of the TAVR market. The stark differences in valve thrombosis (5x less) and structural valve dysfunction (9x less) provide compelling data points for physicians making device selection decisions.

While the structural heart segment represents only a portion of Medtronic's diversified portfolio, TAVR is one of their fastest-growing product lines with continued expansion potential as indications broaden to lower-risk and younger patients. In these populations, long-term valve durability becomes increasingly critical to clinical decision-making.

The data strengthens Medtronic's competitive positioning against Edwards, which has historically dominated the TAVR market. These results could accelerate market share gains in the small annulus segment while supporting premium pricing power. With TAVR procedures projected to grow substantially over the next decade as treatment expands to younger populations, these durability advantages position Medtronic favorably for capturing increased share of this high-margin market.

CRT 2025 Late Breaking Science features largest head-to-head randomized control TAVR trial to primarily enroll women using the two most widely used global TAVR devices

GALWAY, Ireland and WASHINGTON, March 9, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today released the two-year results of the SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial, the largest international head-to-head comparative trial of transfemoral transcatheter aortic valve replacement (TAVR). In patients with aortic stenosis and a small aortic annulus, results showed comparable composite outcome of mortality, disabling stroke, and heart failure hospitalization, and continued superior valve performance as measured by bioprosthetic valve dysfunction (BVD) at two years for Evolut™ TAVR compared to SAPIEN™. The late-breaking science was presented at the Cardiovascular Research Technologies (CRT) 2025 conference in Washington, D.C.

"Valve performance is critical for all patients, but the impact of poor valve performance is magnified in patients with a small aortic annulus, who are at risk of receiving a valve that is not adequate for their cardiac requirements," said Howard C. Herrmann, M.D., Perelman School of Medicine at the University of Pennsylvania, and lead investigator of the trial. "The two-year results highlight the continued superior performance of the Evolut TAVR valve in these patients. While we would not yet expect to see a significant difference in the composite clinical outcomes at this early stage, valve performance provides important data that operators can use to inform and personalize treatment decisions to enhance patient outcomes."

The SMART two-year data demonstrated that Evolut TAVR continues to show significantly less BVD, which can be a predictor of adverse outcomes¹, compared to SAPIEN TAVR. Additional results demonstrated that Evolut TAVR showed the following relative to SAPIEN TAVR:

• Five times less prosthetic valve thrombosis (p=0.0048)
• Nine times less hemodynamic structural valve dysfunction (defined by mean gradient ≥ 20mmHg; p<0.001)

These results build on additional data of Evolut BVD performance in small and large annulus patients, which will be presented as a late-breaker at CRT today, and the Evolut BVD pooled analysis by Dr. Steven Yakobuv published in the Journal of the American College of Cardiology.

The SMART Trial is an international, prospective, multi-center, randomized (1:1) post-market trial comparing the safety and performance of Evolut self-expanding TAVR versus SAPIEN balloon-expandable TAVR in patients with symptomatic severe aortic stenosis (AS) and small aortic annulus. The trial, the largest head to head randomized control trial to primarily enroll women, randomized and treated 716 patients, 87% of which were women, across more than 80 sites worldwide.² Eligible patients had an aortic valve annulus area of ≤430 mm as measured by computed tomography, and suitable anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a SAPIEN 3™/3 Ultra™ valve. Patients enrolled in the trial will continue to be followed out to five years.

"The SMART Trial is a groundbreaking, head-to-head comparison that, for the first time, highlights how a patient with a small annulus can benefit from Evolut's differentiated valve design," said Kendra J. Grubb, M.D., M.H.A, M.Sc., vice president and chief medical officer, Structural Heart, which is part of the Cardiovascular Portfolio at Medtronic. "At two years, we continue to see superior valve performance that we will follow to assess long-term outcomes." 

About Aortic Stenosis 
Aortic stenosis (AS), a narrowing of the aortic valve, is among the most common of all valvular heart diseases, impacting 1.5 million in the U.S.³ Symptomatic severe AS can be fatal if left untreated and the average patient survival is two years without treatment.⁴ Approximately 40% of the total global market is believed to have a small aortic annulus, requiring tailored valve selection for their unique anatomy.

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 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.

¹Généreux, P. et al. J Am Coll Cardiol. 2021;77(21):2717-46
²Herrmann HC, Mehran R, Blackman DJ, Bailey S, Mollmann H, et al. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med. 2024 Jun 6;390(21):1959-1971.
³Carabello BA, Paulus WJ. Aortic stenosis. Lancet. March 14, 2009;373(9667):956-966.
⁴Lester 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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FAQ

What are the key findings of the SMART Trial for Medtronic's Evolut TAVR system at 2 years?

The trial showed Evolut TAVR had 5x less prosthetic valve thrombosis and 9x less hemodynamic structural valve dysfunction compared to SAPIEN TAVR, while maintaining comparable mortality and stroke outcomes.

How many patients were enrolled in MDT's SMART Trial for TAVR devices?

The SMART Trial enrolled 716 patients across 80+ sites worldwide, with 87% being women.

What makes the SMART Trial significant for Medtronic's TAVR research?

It's the largest head-to-head randomized control TAVR trial primarily focusing on small annulus patients and women, comparing the two most widely used global TAVR devices.

How long will patients in MDT's SMART Trial be followed?

Patients enrolled in the trial will continue to be followed for up to five years.