FDA-approved transcatheter heart valve offered to patients

“The system means patients with aortic valve disease who are considered high risk for surgery, now have a new option,” said Deepak Vivek, MD, interventional cardiologist and director, Orlando Health Heart Institute Valve Center. “Patients no longer have to live with severe chest pain, shortness of breath, fatigue and other symptoms of aortic stenosis, or limited treatment options that may not provide lasting results. Patients no longer have to live without hope for improvement. We are excited to bring advanced technology to improve outcomes for our patients.”

The CoreValve System initially was approved by the U.S. Food and Drug Administration (FDA) in January 2014 to treat patients who are too ill or frail to undergo surgery. With this latest approval, the Orlando Health Heart Institute now also offers the CoreValve System to patients who are considered at high risk for a surgical heart procedure, serving a broader range of U.S. patients than any other transcatheter aortic valve.

The FDA approved the CoreValve System to treat patients with severe aortic stenosis who are at high risk for surgery based on groundbreaking research showing the transcatheter heart valve had superior survival rates at one year when compared to open-heart surgery, the current gold standard for aortic valve replacement. The CoreValve System also demonstrated low rates of procedural complications, including stroke, one of the most concerning complications of valve replacement because it can affect survival and quality of life.

The CoreValve 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 or upper chest, and then guided through the arteries into the heart. Once in place, the CoreValve System expands and takes over the original valve’s function to enable oxygen-rich blood to flow efficiently out of the heart.

The advanced design of the CoreValve System is suitable for patients with native valves of nearly all sizes, and it is delivered through the smallest available delivery system, making it possible to treat patients with vascular systems that are small or difficult to navigate. Additionally, the valve’s self-expanding frame enables physicians to deliver the device in a controlled manner, allowing for accurate placement.

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.