The first and only recapturable and repositionable device available in the United States, the Evolut R System is approved for transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis who are at high or extreme risk for surgery. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death.

“This is an amazing time in medicine that we are able to offer cutting edge technology for patients who normally would be deemed inoperable or high risk for open heart surgery. We have an amazing team here at Manatee Memorial Hospital including medical staff, nurses, technicians and ancillary staff that are now ready to move forward in building our structural heart program for the future. As proud as I am of our team, I am even happier that we can make patients feel better with less invasive methods,” said Srinivas Iyengar, MD, Structural Heart Director at Manatee Memorial Hospital.

Kevin DiLallo, CEO of Manatee Healthcare System stated, “Manatee Memorial Hospital is proud to be the only hospital in Manatee, Sarasota and Pinellas counties to offer the TAVR, Watchman Implant and MitraClip procedures to our cardiac patients. These three advanced cardiac services have given new hope to heart patients with serious cardiac conditions.”

Aortic stenosis is a common heart problem caused by a narrowing of the heart’s aortic valve due to excessive calcium deposited on the valve leaflets. When the valve narrows, it does not open or close properly, making the heart work harder to pump blood throughout the body. Eventually, this causes the heart to weaken and function poorly, which may lead to heart failure and increased risk for sudden cardiac death.

The CoreValve Evolut R System replaces a diseased aortic heart valve through a minimally invasive procedure, without open-heart surgery and without surgical removal of the diseased valve. The device is typically inserted via an artery in the leg and then guided through the arteries into the heart. Once in place, the device expands and takes over the original valve’s function to enable oxygen-rich blood to flow efficiently out of the heart.

The approval of Evolut R as the first self-expanding, recapturable and repositionable transcatheter heart valve available in the U.S. represents a significant advancement in the TAVR industry. The CoreValve Evolut R System is built on the proven foundation and procedural success of the CoreValve System, which has been implanted in more than 75,000 patients in 60 countries.