IDE Trial Approved for Medtronic's Evolut R TAVR System in Low-Risk Patients

February 22, 2016—Medtronic plc announced that the US Food and Drug Administration (FDA) approved an expanded indication trial for the CoreValve Evolut R system, the company’s next-generation, recapturable, self-expanding transcatheter aortic valve replacement (TAVR) system. The trial will enroll patients with aortic stenosis who are at a low surgical mortality risk, as determined by a heart team.

The CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R delivery catheter system were FDA approved for commercial use in the United States in June 2015. Also, it received European CE Mark approval and is commercially available in Europe and other countries that recognize the CE Mark.

According to Medtronic, enrollment for the investigational device exemption (IDE) trial is expected to begin during the spring of 2016 and will include 1,200 patients with severe aortic stenosis who have a < 3% risk of mortality, as determined by a heart team. The trial will enroll low-risk patients at up to 80 clinical sites with 1:1 randomization to receive the Evolut R system or undergo surgical aortic valve replacement (SAVR).

The IDE-adaptive trial has a primary endpoint of all-cause mortality or disabling stroke. The trial has a 2-year endpoint and allows for a 1-year analysis for early FDA submission. Additionally, the trial will include a substudy of leaflet mobility in 400 patients.

In the company’s press release, the IDE trial’s Principal Investigator, Michael Reardon, MD, commented, “This trial comes on the heels of data showing patients who underwent TAVR with this self-expanding platform demonstrating superior survival benefit—with low and stable stroke rates—compared to SAVR patients.”

Dr. Reardon, who is Professor of Cardiothoracic Surgery at Houston Methodist DeBakey Heart & Vascular Center in Houston, Texas, added, “This study is an important next step in developing robust clinical evidence to help heart teams understand the potential benefits of TAVR in a broader patient population.”

Medtronic advised that the Evolut R system is optimized to increase conformability and sealing at the annulus while maintaining supra-annular valve positioning for improved blood flow and hemodynamic performance. The valve is delivered through the EnVeo R delivery catheter system, which features an inline sheath with a 14-F equivalent low profile. The system’s low profile enables treatment of patients with vessels as small as 5 mm through the preferred transfemoral access route and may minimize the risk of major vascular complications in some patients, stated the company.