Mount Sinai Medical Center selected to participate in Corevalve Clinical Trial

Mount Sinai Medical Center in Miami Beach, Florida announced its participation in the Medtronic CoreValve U.S. Clinical Trial, which will evaluate a new, non-surgical alternative to open-heart surgery for patients with severe aortic stenosis. Mount Sinai is now among a select number of leading hospitals across the U.S. to participate in this trial.

“We’re excited to partner with other leading cardiac specialists in the U.S. to study this revolutionary technology,” said Dr. Joseph Lamelas, Chief of Cardiac Surgery at The Mount Sinai Heart Institute. “The boundaries of medical treatment are constantly being expanded, and Mount Sinai is proud to stand with our patients on that frontier.”

The CoreValve System is designed to provide a minimally invasive, nonsurgical treatment option for patients with symptomatic, severe aortic stenosis who are at high risk, or are ineligible, for open-heart surgery. Worldwide, approximately 300,000 people have been diagnosed with this condition (100,000 in the U.S.), which occurs when the heart’s aortic valve is narrowed, restricting blood flow from the heart to the body. Approximately one-third of these patients are deemed at too high a risk for open-heart surgery as the condition typically affects an older demographic and develops in individuals between the ages of 50 and 70. The Medtronic CoreValve U.S. Clinical Trial will evaluate the safety and effectiveness of the CoreValve Transcatheter Aortic Valve System in these groups of patients.

“The procedure we are evaluating does not require open-heart surgery or surgical removal of the native valve, which makes this potential treatment option especially desirable because so many patients with aortic stenosis are not able to withstand surgery,” said Lamelas.

The Medtronic CoreValve System is a new technology designed to replace a diseased aortic heart valve percutaneously – meaning through the skin – without open heart surgery and without surgical removal of the diseased valve. The new valve replacement procedure channels a catheter (thin tube) with a prosthetic valve through the femoral artery to reach the heart. The CoreValve System is designed with self-expandable technology, deploying the new valve inside the diseased aortic valve without openheart surgery or surgical removal of the native valve.

The Medtronic CoreValve U.S. Clinical Trial will enroll a total of more than 1,200 patients at 40 U.S. clinical sites, including Mount Sinai Medical Center. Outside the U.S., CoreValve received CE (Conformité Européenne) Mark in Europe in 2007.

Mount Sinai Medical Center is currently enrolling patients in the trial. For more information about participating in this clinical trial, contact at 305-674-2399

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