Medtronic Evolut™ TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

Rhea-AI Summary

Medtronic (NYSE: MDT) has announced compelling five-year outcomes from the Evolut Low Risk Trial for its Evolut™ TAVR system. The study, involving 1,414 patients (730 TAVR, 684 surgery), demonstrated that TAVR patients experienced comparable rates of all-cause mortality or disabling stroke (15.5%) versus surgery (16.4%) at five years.

Key findings showed a numerically lower rate of cardiovascular mortality in TAVR patients (7.2%) compared to surgery (9.3%), along with significantly larger effective orifice areas and lower mean gradients. The trial evaluated patients with severe aortic stenosis who had a predicted 30-day mortality risk below 3%.

The results, presented at the American College of Cardiology's Annual Scientific Session & Expo, support Evolut's supra-annular, self-expanding TAVR as a durable and effective alternative to surgery for severe aortic stenosis patients, regardless of surgical risk.

Positive

• Comparable 5-year mortality rates between TAVR (15.5%) and surgery (16.4%)
• Lower cardiovascular mortality trend in TAVR patients (7.2%) vs surgery (9.3%)
• Superior valve performance with larger orifice areas and lower mean gradients
• Demonstrated long-term durability and safety in low-risk patients

Negative

• None.

Insights

Medical Device Specialist

The five-year data from Medtronic's Evolut Low Risk Trial represents a significant milestone for the company's TAVR technology. The results showing comparable rates of all-cause mortality or disabling stroke between TAVR (15.5%) and surgery (16.4%) effectively removes one of the final barriers to broader TAVR adoption in low-risk patients – concerns about long-term durability.

The numerically lower cardiovascular mortality rate (7.2% vs. 9.3%) and statistically significant improvements in hemodynamic parameters (valve opening area and pressure gradients) differentiate Evolut from surgical valves in meaningful ways. These hemodynamic advantages typically translate to better long-term outcomes as patients age.

From a competitive standpoint, these results strengthen Medtronic's position against Edwards Lifesciences in the expanding TAVR market. The low-risk segment represents the largest potential patient population, and durability data is crucial for physician decision-making when treating younger patients with longer life expectancies.

This trial validates Medtronic's self-expanding, supra-annular valve design approach, which appears to deliver excellent long-term hemodynamic performance. The data aligns with and reinforces the recently reported SMART trial results, creating a compelling body of evidence supporting Evolut TAVR as a first-line treatment option across risk categories.

Cardiology Expert

The five-year Evolut Low Risk Trial data transforms the treatment paradigm for aortic stenosis. With mortality outcomes matching surgery and superior hemodynamics, interventional cardiologists now have robust evidence supporting TAVR as a durable option even for younger, healthier patients.

The clinical significance extends beyond the primary endpoint. While the all-cause mortality/disabling stroke composite endpoint showed numerical but non-statistically significant advantages (15.5% vs. 16.4%, p=0.47), the consistently better hemodynamic performance is particularly meaningful. Larger effective orifice areas and lower mean gradients typically correlate with reduced long-term complications like patient-prosthesis mismatch, which can lead to heart failure and reduced survival.

The 7.2% cardiovascular mortality rate (vs. 9.3% with surgery) suggests the hemodynamic benefits may translate to improved cardiovascular outcomes, though this didn't reach statistical significance (p=0.15).

These results will likely accelerate the ongoing shift from surgical to transcatheter approaches, particularly in the low-risk category where surgery has remained the default option. Physicians can now confidently recommend TAVR with Evolut to patients regardless of surgical risk classification, knowing the valve delivers durable performance through at least five years. This represents a substantial expansion of Medtronic's addressable patient population and positions their self-expanding valve technology favorably in this rapidly growing therapeutic area.

GALWAY, Ireland and CHICAGO, March 30, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut™ transcatheter aortic valve replacement (TAVR) system delivers a numerically lower rate of all-cause mortality or disabling stroke at five years, strong valve performance and durable clinical outcomes. The findings were presented as late-breaking clinical science at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in the JACC, the flagship journal of the American College of Cardiology.

The Evolut Low Risk Trial was a randomized, multicenter, international study assessing the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients. These patients had a predicted 30-day mortality risk <3%, as assessed by a local heart team. 1,414 patients were randomized, with 730 receiving TAVR with either a Medtronic Evolut R, PRO, or CoreValve™ and 684 undergoing surgery.

"Results at five years support Evolut's supra-annular, self-expanding TAVR as a safe, effective, and durable alternative to surgery for patients with severe aortic stenosis, regardless of their surgical risk," said Michael J. Reardon, M.D., Allison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital and principal investigator of the trial. "The lower mortality risk and strong valve performance is meaningful for clinicians in evaluating treatment approaches that prioritize the overall well-being of patients."

Patients with severe aortic stenosis who were treated with either Evolut TAVR or surgery showed comparable rates of all-cause mortality or disabling stroke at 5 years (Evolut TAVR [15.5%] and surgery [16.4%]; p=0.47). Additional findings at five years include:

• Numerically lower rate of cardiovascular mortality (7.2% Evolut TAVR vs. 9.3% surgery; p=0.15)
• Significantly larger effective orifice areas (EOA) and lower mean gradients in the TAVR vs. surgical arms

"At five years, Evolut has demonstrated lasting clinical outcomes comparable to surgery and a trend toward reduced cardiovascular mortality," said Kendra J. Grubb, M.D., M.H.A., M.Sc., vice president and chief medical officer of Structural Heart, which is part of the Medtronic Cardiovascular Portfolio. "These results reinforce the recently reported Evolut evidence from the SMART trial,[1] which emphasized superior hemodynamics and lower rates of valve dysfunction. The Evolut Low Risk data presented today will help clinicians make personalized treatment decisions for younger, lower-risk patients by considering each patient's unique needs, now acknowledging that data supports TAVR with Evolut as a safe and durable alternative to surgery."

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.

Contact:

Kimberly Powell
Public Relations
+1-202-498-2601

Ryan Weispfenning
Investor Relations
+1-763-505-4626

¹Herrmann H. Two-Year Outcomes of the Five-Year SMART Trial, presented at CRT 2025.

 

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SOURCE Medtronic plc

FAQ

What are the 5-year mortality rates for Medtronic's Evolut TAVR system compared to surgery?

The Evolut TAVR system showed a 15.5% all-cause mortality or disabling stroke rate compared to 16.4% for surgery, with cardiovascular mortality rates of 7.2% vs 9.3% respectively.

How many patients were included in Medtronic's Evolut Low Risk Trial?

The trial included 1,414 patients total, with 730 receiving TAVR treatment and 684 undergoing surgery.

What types of Medtronic TAVR devices were used in the Evolut Low Risk Trial?

The trial used Medtronic Evolut R, PRO, or CoreValve™ devices for TAVR procedures.

What were the key performance advantages of MDT's Evolut TAVR system?

The Evolut TAVR system demonstrated significantly larger effective orifice areas and lower mean gradients compared to surgery at five years.

What was the patient risk profile in the Medtronic Evolut Low Risk Trial?

The trial included patients with severe aortic stenosis who had a predicted 30-day mortality risk less than 3%, as assessed by local heart teams.