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El Camino Hospital Offers New FDA-Approved Transcatheter Heart Valve Therapy For Patients Who Are At High Risk To Undergo Open-Heart Surgery
Date:8/14/2014

MOUNTAIN VIEW, Calif., Aug. 14, 2014 /PRNewswire/ -- El Camino Hospital 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 considered to be 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 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 demonstrated exceptional clinical outcomes during the U.S. pivotal trial," said Rhonda Robb, vice president and general manager of Catheter Based Therapies at Medtronic. "We are pleased that the CoreValve System is now available to the broadest range of patients with severe aortic stenosis."

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.

"The recent FDA approval of the CoreValve System is a significant milestone for patients with severe aortic stenosis who previously had no other treatment options," said James Joye, D.O., interventional cardiologist at El Camino Hospital. "We are proud to have been one of the only community hospitals in the nation to participate in the groundbreaking clinical results that led to this approval."

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