Medtronic Announces Five-Year Clinical Data Demonstrating Evolut TAVR's Superiority Over SAVR in Low-Risk Severe Aortic Stenosis Patients

Mar 31, 2025 22:16 CST Updated 22:16

Medtronic

Medical Device Manufacturer

Medtronic inAmerican College of Cardiology (ACC) PublishEvolutAndFive-year clinical study data comparing SAVR, the study showsEvolut GroupDemonstrates a lower all-cause mortality or disabling stroke rate within five years, while exhibiting excellent valve performance and sustained clinical outcomes.

This clinical study is a randomized, multicenter, international study designed to evaluate the safety and efficacy of Evolut versus SAVR in low-risk patients. Patients were enrolled after evaluation by the local heart team, predicting a 30-day mortality risk of <3%. The study included a total of 1,414 patients, with 730 receiving TAVR treatment using Medtronic's Evolut R, PRO, or CoreValve, and 684 undergoing surgical procedures.

Research Data

All-Cause Mortality / Disabling Stroke: There was no statistical difference in the five-year incidence between the TAVR group and the surgical group (15.5% vs. 16.4%; p=0.47).
Cardiovascular Mortality: The TAVR group showed a numerical decreasing trend (7.2% vs. 9.3%; p=0.15).
Hemodynamic Manifestations: The TAVR group had a significantly larger effective orifice area (EOA) and a lower mean transvalvular pressure gradient.

PI Evaluation

"Five-year data confirm that, regardless of patient surgical risk, the Evolut with its supra-annular self-expanding design is a safe, effective, and durable alternative to surgical options for patients with severe aortic stenosis. Lower mortality risk and excellent valve performance will help clinicians develop treatment strategies focused on long-term patient health."

---Michael J. Reardon the Houston Methodist Hospital

Executive Evaluation

"The five-year data not only validated the long-term clinical outcomes of Evolut TAVR as comparable to surgical procedures but also demonstrated a potential advantage in reducing cardiovascular mortality." Combined with the recently published SMART trial results — which confirmed Evolut's superior hemodynamics and lower rate of valve dysfunction — the data released today will support clinicians in developing personalized treatment plans for younger, low-risk patients, offering TAVR as a safe and durable alternative therapy based on individual needs."

---Kendra J. Grubb Vice President and Chief Medical Officer of Medtronic's Structural Heart Disease Business

Evolut FX+

Evolut FX+It was Medtronic's fourth-generation TAVR---Upgraded from Evolut FX,Its biggest highlight is solving the problem of coronary artery access.

InEvolut FX+Before its launch, Medtronic introduced three imaging markers on the Evolut FX to assist doctors in confirming commissural alignment during the TAVR procedure.

According to extensive clinical studies, whether the commissures are aligned directly affects coronary access, valve hemodynamics, and the durability of the prosthetic valve.

Of course, due to the different physiological structures of each patient,Alignment of the anastomosis does not necessarily guarantee perfect avoidance of the coronary ostium. Therefore, Medtronic has designed according to clinical needs.Evolut FX+。Evolut FX+On the basis of retaining the three radiopaque markers of Evolut FX, it provides a larger coronary access window. This opening size is four times that of the previous Evolut series. Such a designEvolut FX+ provides more space for the operability of the catheter, facilitating access to coronary arteries with different patient anatomies.。

At the same time, newly establishedThe plan will not harm the marketLeading valve performance, excellent hemodynamics, and clinicians' expectations for the radial strength of the Evolut platform.

Medtronic

Headquartered in Dublin, Ireland, Medtronic is one of the largest medical technology, services, and solutions companies in the world — alleviating pain, restoring health, and extending life for millions of people globally. With over 90,000 employees worldwide, Medtronic serves doctors, hospitals, and patients in more than 150 countries. The company focuses on collaborating with stakeholders around the world to advance healthcare.