News | October 27, 2014

FDA-Approved Heart Valve Therapy Available For Patients at High Risk to Undergo Open-Heart Surgery

CoreValve system now available to more U.S. patients than any other transcatheter aortic valve

Oct. 27, 2014 — El Camino Hospital in Mountain View, Calif., became one of the first hospitals in California to adopt a new minimally invasive system to treat patients with narrowed, failing aortic heart valves who are at high risk to undergo surgery.

The U.S. Food and Drug Administration (FDA) approved the Medtronic CoreValve System to treat patients with severe aortic stenosis who are at high risk for surgery based on research showing the transcatheter heart valve had higher 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.

El Camino Hospital was one of 45 U.S. sites involved in the High Risk Study of the CoreValve U.S. Pivotal Trial, which led to the FDA approval of the CoreValve System.

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. Eventually, this may lead to heart failure and increased risk for sudden cardiac death.

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 CoreValve System initially was approved by the FDA in January 2014 to treat patients who are too ill or frail to undergo surgery. With this latest approval, El Camino Hospital 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 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.

For more information: www.corevalve.com

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