February 23, 2016 — The U.S. Food and Drug Administration (FDA) approved an expanded indication trial for low-risk surgical patients using Medtronic’s CoreValve Evolut R System transcatheter aortic valve replacement (TAVR) system. Patients with aortic stenosis, who are at a low surgical mortality risk as determined by a heart team, will be enrolled in the trial.
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 less than 3 percent risk of mortality, as determined by a heart team. The trial will enroll low-risk patients from up to 80 clinical sites with 1:1 randomization to receive the Evolut R System or undergo open-heart surgery (surgical aortic valve replacement or SAVR). The IDE is designed as an adaptive trial with a primary endpoint of all-cause mortality or disabling stroke. The trial has a two-year endpoint and allows for a one-year analysis for early FDA submission. Additionally, the trial will include a sub-study of leaflet mobility in 400 patients.
“This trial comes on the heels of data showing patients who underwent TAVR with this self-expanding platform demonstrated superior survival benefit — with low and stable stroke rates — compared to SAVR patients,” said Michael Reardon, M.D., professor of cardiothoracic surgery at Houston Methodist DeBakey Heart & Vascular Center and principal investigator of the IDE study. “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.”
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 that provides what Medtronic calls the lowest profile on the market (14 Fr equivalent, less than 1/5 inch). The low profile enables treatment of patients with vessels down to 5mm through the preferred transfemoral access route, and may minimize the risk of major vascular complications in some patients.
The transcatheter valve and the delivery catheter system were FDA-approved for commercial use in the United States in June 2015. It is also available in Europe and other countries that recognize the CE mark.
In January, the FDA approved a similar IDE trial examining the use of the Edwards Lifesciences Sapien 3 TAVR device in low-risk surgical patients.
For more information: www.medtronic.com