Medtronic Announces Two-Year SMART Trial Results Demonstrating Superior Valve Performance of Evolut TAVR Over SAPIEN in Small Annulus Patients

Mar 10, 2025 22:15 CST Updated 22:15

Medtronic

Medical Device Manufacturer

Medtronic inCardiovascular Research Technologies (CRT) 2025 ConferencePublication of the SMART Trial (Evolut and SAPIEN TreatmentTwo-Year Results of the Head-to-Head Clinical Study in Patients with Small Annuli.Research shows:Evolut and SAPIENThe composite endpoint results for two-year mortality, disabling stroke, and heart failure hospitalization were comparable, butEvolut Has Superior Bioprosthetic Valve Dysfunction (BVD).

Specific Research Data

Two-year data from the SMART trial show that, compared to SAPIEN, Evolut continues to demonstrate a significantly lower rate of BVD (BVD can serve as a predictor of adverse outcomes). Other results indicate that Evolut is significantly superior to SAPIEN in the following aspects:

The incidence of thrombosis in prosthetic valves was reduced fivefold (p=0.0048).
The incidence of hemodynamic structural valve dysfunction (defined as a mean transvalvular pressure gradient ≥20mmHg) was reduced ninefold (p<0.001).

PI Evaluation

"Valve performance is crucial for all patients, but for patients with small aortic annuli, the impact of suboptimal valve performance is amplified, as these patients face the risk of the implanted valve failing to meet cardiac demands. Two-year data highlights the sustained superior performance of the Evolut TAVR valve in this patient population. Although no significant differences in composite clinical endpoints have been observed at this stage, valve performance provides important insights for operators, aiding in the development of personalized treatment strategies to improve patient outcomes."

--- Howard C. Herrmann University of Pennsylvania

Executive Evaluation

"The SMART trial pioneered the head-to-head clinical study of TAVR, and for the first time confirmed that patients with small annulus can benefit from the unique valve design of Evolut. The two-year data continuously validates its superior valve performance, and we will continue to track and evaluate long-term outcomes."

---Kendra J. Grubb Vice President and Chief Medical Officer of Structural Heart Disease Business in the Cardiovascular Field at Medtronic

Evolut FX+ (Medtronic's Latest TAVR)

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 maneuverability of the catheter to facilitate access to coronary arteries with different patient anatomies.。

At the same time, newly establishedThe plan will not harm the market.Leading valve performance, excellent hemodynamics, and the radial strength expected by clinicians from the Evolut platform.

Medtronic

Medtronic, headquartered in Dublin, Ireland, 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.