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

Related Content

Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
TCT 2017 late-breaking trials and studies that will be presented on the latest cardiology technology clinical trials.
Feature | September 11, 2017
September 11, 2017 — From numerous high-quality submissions, Transcatheter Cardiovascular Therapeutics (TCT) has sele
Protembis Announces Successful First-in-Human Use of  ProtEmbo Cerebral Protection System in European Trial
News | Embolic Protection Devices| September 07, 2017
Protembis GmbH announced the first clinical applications of its ProtEmbo Cerebral Protection System to complement a...
Minneapolis Heart Institute Foundation Enrolls First Patient in TRILUMINATE Tricuspid Repair Trial
News | Heart Valve Technology| September 05, 2017
Minneapolis Heart Institute Foundation announced it has enrolled the first-in-the-world patient in a clinical study to...
World's First Successful 52-mm Transcatheter Tricuspid Valve Implantation Completed in Italy
News | Heart Valve Technology| August 31, 2017
NaviGate Cardiac Structures Inc. (NCSI) announced that its Gate catheter-guided tricuspid atrioventricular valved stent...
Sponsored Content | Videos | Heart Valve Technology| August 30, 2017
Azeem Latib, M.D., MBBCh, FCP, interventional cardiologist at Columbus Hospital in Milan, Italy, discusses the latest
PinnacleHealth First in Pennsylvania to Implant Sentinel Cerebral Protection System
News | Embolic Protection Devices| August 23, 2017
PinnacleHealth is the first hospital in Pennsylvania and one of the first 10 in the country to introduce new technology...
CMS Awards New Technology Add-on Payment for Perceval Sutureless Aortic Heart Valve
News | Heart Valve Technology| August 22, 2017
August 22, 2017 — LivaNova PLC announced its Perceval ...
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Overlay Init