Inova Becomes First Hospital in Mid-Atlantic Region to Successfully Implant CoreValve Device as Part of a Clinical Trial

Falls Church, VA – (May 16, 2011) – Heart specialists at Inova Heart and Vascular Institute are taking part in a clinical trial to evaluate a treatment alternative to open-heart surgery for high-risk patients with severe aortic stenosis. Under the direction of Niv Ad, MD, Chief of Cardiac Surgery and Medical Director, Cardiac Surgery Research, Inova Heart and Vascular Institute; and Bryan Raybuck, MD, Medical Director, Catheterization Laboratories, Inova Heart and Vascular Institute, the Medtronic CoreValve®  U.S. Clinical Trial assesses a revolutionary minimally invasive surgical procedure to replace the diseased aortic valve. Inova is one of just 40 hospitals across the U.S. to participate in this trial and successfully implanted the device in a patient from Maryland last month.

During the procedure, a team consisting of a heart surgeon and an interventional cardiologist channel the CoreValve system, composed of a catheter mounted with a porcine, prosthetic valve, through the patient’s femoral artery to reach the heart, where it self-expands to replace the diseased aortic valve. The procedure is completed without open-heart surgery or surgical removal of the native valve.

“There is significant need for new treatment options for high-risk patients with severe aortic stenosis,” said Dr. Bryan Raybuck. “Currently, open-heart surgery is the only effective treatment option, but not all patients are candidates for surgery. This will hopefully be an alternative option for patients who require a less invasive procedure.”

The procedure is a collaborative effort, bringing together cardiologists and cardiac surgeons. Inova’s newly opened hybrid operating room (OR) provides the setting necessary to perform this trial in an environment that’s safe for the patient. The hybrid OR allows both cardiologists and cardiac surgeons to work together with the tools from a catheterization lab and an OR in one setting.

“For decades we have performed cutting-edge, open-heart surgical procedures to treat patients with valve disease. This, combined with the latest hybrid operating room technology at Inova Heart and Vascular Institute, brought this exciting minimally invasive technology to Northern Virginia,” said Dr. Niv Ad. “We’re excited to be on the cutting-edge of developing new procedures and to have the ability to offer them to our high-risk patients.”

Aortic stenosis prevents the heart’s aortic valve from opening completely, thereby preventing healthy blood flow from the aorta to the rest of the body. Untreated, aortic valve stenosis leads to serious heart problems. About 100,000 people in the U.S. have been diagnosed with severe aortic stenosis.

The CoreValve System will not be commercially available in the U.S. until the successful completion of this clinical trial and approval by the U.S. Food and Drug Administration. For more information about the Medtronic CoreValve U.S. Clinical Trial, visit www.aorticstenosistrial.com or the NIH’s clinical trials website.

Inova Health System is a not-for-profit healthcare system based in Northern Virginia that consists of hospitals and other health services, including emergency- and urgent-care centers, home care, nursing homes, mental health and blood donor services, and wellness classes. Governed by a voluntary board of community members, Inova’s mission is to improve the health of the diverse community it serves through excellence in patient care, education and research. Inova provides a healthy environment for its patients, families, visitors, staff and physicians by prohibiting tobacco use on its campuses.

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