Apr 4, 2022

Medtronic TAVR platform first and only to demonstrate durability benefit over SAVR at 5 years

ACC.22: Late-breaking data show CoreValve™ and Evolut™ is the only platform to out-perform surgery in valve durability at five years


Medtronic today unveiled new insights from a pooled analysis of high and intermediate risk patients from the CoreValve/Evolut program, showing a lower occurrence in structural valve deterioration (SVD) in patients with severe aortic stenosis (AS) at high or intermediate surgical risk undergoing supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) compared to surgery. The data were presented as a late-breaking clinical trial at the American College of Cardiology’s 71st Annual Scientific Session (ACC.22).

To compare SVD rates between randomized patients who underwent TAVR and surgery, 1,484 intermediate risk (792 TAVR, 692 SAVR) and 615 high risk (336 TAVR, 279 SAVR) patients were evaluated for SVD. In patients with symptomatic severe AS at intermediate or high surgical risk, the 5-year rate of SVD was 4.38% in patients undergoing surgery, versus 2.57% in patients undergoing TAVR (P=0.0095). The risk of death and rehospitalization for aortic valve disease or heart failure approximately doubles in patients that develop SVD, according to the pooled analysis.

The analysis also showed a higher risk of developing SVD in younger patients, women, and patients with a higher body surface area (BSA). To date, only CoreValve and Evolut transcatheter aortic valve replacement systems are shown in randomized clinical trials to out-perform surgery in valve durability at 5 years.

“As TAVR is being used among a wider patient population, valve durability is becoming more important to clinicians when selecting a treatment option. Patients need a valve that can accommodate their activity levels while remaining hemodynamically stable for years to come,” said Michael J. Reardon, M.D., professor of cardiothoracic surgery and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center, principal investigator in the SURTAVI trial. “These outcomes confirm what clinicians have long believed about Evolut and CoreValve and allow for greater confidence in the strength of the platform regardless of patient’s overall surgical risk.”

The Medtronic TAVR technologies, which includes the Evolut™ R, Evolut™ PRO, Evolut™ PRO+, and newest-generation Evolut™ FX systems, are indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low).                                                                      

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.

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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 90,000+ 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 Twitter and LinkedIn.


Wendy Dougherty
Public Relations

Ryan Weispfenning
Investor Relations