FDA Approves Low-Risk Indication for Medtronic's Evolut TAVR System

August 16, 2019–Medtronic announced FDA approval of the company's Evolut transcatheter aortic valve replacement (TAVR) system for patients with symptomatic severe native aortic stenosis who are at a low risk of surgical mortality.

The expanded indication approval is based on data from the EVOLUT Low-Risk randomized clinical trial, which evaluated three generations of Medtronic TAVR systems (CoreValve, Evolut R, and Evolut Pro) in more than 1,400 patients.

Coprincipal Investigator Michael J. Reardon, MD, presented the 24-month data from the EVOLUT Low-Risk trial at the American College of Cardiology's 68th Annual Scientific Session, held March 16–18, 2019, in New Orleans, Louisiana. The findings were simultaneously published by coprincipal investigator Jeffrey J. Popma, MD, et al in The New England Journal of Medicine (2019;380:1706–1715).

According to Medtronic, the data showed TAVR to have an excellent safety profile and to be an effective treatment option in low-risk patients with shorter hospitals stays and improved quality-of-life scores compared to surgical aortic valve replacement. TAVR with the Evolut system demonstrated a significantly lower rate of the composite of all-cause death or disabling stroke, as well as superior hemodynamic performance with significantly lower mean aortic valve gradients and larger effective orifice area compared to surgery. The rate of new pacemaker implantation and residual aortic regurgitation was higher in the TAVR group, noted the company.

In Medtronic's announcement, Dr. Reardon commented, “The majority of my patients want a replacement valve that’s going to minimize the risk of death, stroke, and other cardiovascular events during the procedure and allow them to leave the hospital faster and recover sooner. In patients appropriate for a biologic valve, that option is going to be TAVR. With the low-risk approval, risk stratification for TAVR treatment is becoming obsolete and heart teams will likely need to assess treatment options based on anatomical characteristics, concomitant risk factors, and also patient preference.” Dr. Reardon is a cardiothoracic surgeon at Houston Methodist DeBakey Heart & Vascular Center in Houston, Texas.

Dr. Popma, who is Director of Interventional Cardiology at Beth Israel Deaconess Medical Center in Boston, Massachusetts, stated, “Low-risk patients were younger and healthier than those patients enrolled in our prior studies, and were better able to weigh the risks and benefits of surgery or TAVR based on their value preferences. It is our impression that patients will now be able to make a choice on the method of aortic valve replacement based on an informed risk-benefit discussion with their heart team.”

Medtronic noted that the low-risk patient population is the final surgical risk category to be approved for this minimally invasive alternative to open-heart surgical valve replacement and includes patients who may be younger and more active than higher-risk patients. With the approval, the Evolut TAVR platform is now indicated in the United States for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low).