Most Popular Angioplasty Web Site
Stent Center Stent Center
with support from Medtronic Cardiovascular
FDA Gives Approval to Medtronic's CoreValve for Use in Patients at Intermediate Risk for Surgical Valve Replacement
More Patients with Symptomatic, Severe Aortic Stenosis Will Now Be Eligible for Treatment with Self-Expanding Transcatheter Valves
Share This Story:
Bookmark and Share

3 generations of CoreValve
CoreValve, CoreValve Evolut R and CoreValve Evolut PRO
July 10, 2017 -- Based on results from the landmark SURTAVI Clinical Trial, presented at the American College of Cardiology Annual Meeting in March, and published in the New England Journal of Medicine, the FDA has approved the CoreValve TAVR self-expanding platform for use in patients with severe and symptomatic aortic stenosis who are at "intermediate" risk for surgical valve replacement, defined as mortality >= 3% at 30 days.

This risk assessment is made by a hospital's "Heart Team," which includes both interventional and surgical specialists, and utilizes criteria such as the Society of Thoracic Surgeons (STS) score and other factors relating to the individual's clinical profile.

The expanded indication applies to all CoreValve devices currently approved by the FDA, the CoreValve, CoreValve Evolut R, and the recently approved CoreValve Evolut PRO.

Previously, the CoreValve was only approved in patients at high-risk for surgery. But, as has been the case with the Edwards Sapien TAVR, as studies are done and new iterations of these devices are made available, the results of transcatheter valve procedures come closer ("non-inferior") to their surgical counterparts, and in some measures are superior.

For example, while the CoreValve Evolut was non-inferior to surgical valve replacement (SAVR) for all-cause mortality or disabling stroke (12.6% for TAVR vs. 14.0% for SAVR), the CoreValve device showed significantly better mean aortic valve gradients at two years (7.8mm Hg vs. 11.8mm Hg; p<0.001). SAVR did result in less aortic regurgitation, major vascular complications, and permanent pacemaker implantation, but device development is a moving target. For example, the newest iteration of the CoreValve (the Evolut PRO), which was not part of the SURTAVI Trial, has shown dramatic reductions in most of these measures.

This morning's press release from Medtronic follows:

Medtronic Expands TAVR Access to More Patients With Symptomatic, Severe Aortic Stenosis Upon Intermediate Risk FDA Approval
Self-Expanding CoreValve™ Evolut™TAVR Platform with Excellent Procedural Safety and Proven Valve Performance Helps Address Needs of Intermediate-Risk Patients

July 10, 2017 -- Dublin -- Medtronic plc (NYSE: MDT) today announced the expanded U.S. Food and Drug Administration (FDA) approval of the self-expanding CoreValve™ Evolut™ transcatheter aortic valve replacement (TAVR) platform to include patients with symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery. With hemodynamic performance (a measure of blood flow efficiency) shown to be superior to surgical aortic valve replacement (SAVR), the CoreValve Evolut platform is designed to deliver excellent valve performance for these patients who are often considered to be more active than high- or extreme-risk patients previously indicated for the procedure.

Patients who are at intermediate risk for open-heart surgery have a risk of mortality of >= 3 percent at 30 days following the procedure. The risk assessment is determined by a heart team (including an interventional cardiologist and cardiac surgeon), in combination with the Society of Thoracic Surgeons (STS) score and other factors, such as co-morbidities, frailty, prior surgical intervention and disabilities.

Dr. Michael J. Reardon
Dr. Michael J. Reardon

"As evidenced by the landmark SURTAVI trial, the CoreValve Evolut platform is well-suited for the intermediate-risk patient population due to its supra-annular design for unsurpassed hemodynamics, low rates of mortality and disabling stroke, earlier improvement in quality of life, fast functional recovery times and short hospital stays," said Michael Reardon, M.D., professor of cardiothoracic surgery and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center. "It's important to consider that in the first 30 days, patients treated with TAVR showed functional improvements and lower rates of stroke than the surgical patients in the study."

Recently unveiled at the 2017 American College of Cardiology meeting, the global SURTAVI trial evaluated intermediate-risk patients and compared 863 TAVR patients treated with the CoreValve and Evolut R Systems (STS: 4.4 percent) to 794 surgical patients (STS: 4.5 percent). Against the strongest surgical performance (compared to predicted surgical risk of mortality) seen to date in a randomized trial, the CoreValve Evolut platform met its primary endpoint of non-inferiority compared to surgery in all-cause mortality or disabling stroke (12.6 percent for TAVR versus 14.0 percent for SAVR; posterior probability of non-inferiority >0.999). The CoreValve Evolut platform also demonstrated significantly better mean aortic valve gradients (7.8 mm Hg vs. 11.8 mm Hg; p<0.001) at two years. SAVR was associated with less aortic regurgitation, major vascular complications and need for permanent pacemaker implantation.

"Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population," said Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, a part of Medtronic's Cardiac and Vascular Group. "We are delighted to take the self-expanding CoreValve Evolut platform to more patients with aortic stenosis who can benefit from this therapy."

The CoreValve Evolut platform consists of the CoreValve, CoreValve Evolut R and the recently FDA-approved CoreValve Evolut PRO systems, which are available for use in the United States with severe aortic stenosis patients at an intermediate surgical risk or greater. The CoreValve Evolut PRO System is currently not approved for commercial use outside of the United States.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic
Medtronic plc (, headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 91,000 people worldwide, serving physicians, hospitals and patients in more than 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Reported by Burt Cohen, July 10, 2017