News Release: Emory Healthcare , Research , School of Medicine

Nov. 3,  2011

New Valve Revolutionizes the Treatment of Aortic Stenosis

ATLANTA - The United States Food and Drug Administration (FDA) has given the green light to a new transcatheter heart valve, under study at Emory since 2007, and expected to revolutionize the treatment of severe aortic stenosis.

The device called the SAPIEN valve, developed by Edwards Lifesciences, offers a new non-surgical treatment option for patients with failing aortic valves. Emory University Hospital was one of 23 sites nationwide, and the only one in Georgia, to study transcatheter aortic valve implantation (TAVI) with the SAPIEN valve.

Aortic stenosis is a life-threatening heart condition that affects tens of thousands of Americans each year when the aortic valve tightens or narrows, preventing blood from flowing through normally.

During the TAVI procedure, doctors create a small incision in the groin or chest wall and then feed the new valve made of cow heart tissue, mounted on a wire mesh on a catheter, and place it where the new valve is needed. This offers a non-invasive way for doctors to treat patients who are not candidates for traditional surgery.

"This is a major milestone in the treatment of heart disease," says Emory Heart & Vascular Center cardiologist Vasilis Babaliaros, MD, associate professor of medicine at Emory University School of Medicine.

"The development of this procedure and this FDA approval will allow us to help even more patients with valvular heart disease and could mean the difference between life or death for a countless number of patients who are too sick or weak to undergo open-heart surgery to replace their diseased valves."

Babaliaros traveled to France to learn the new lifesaving approach, training for several years alongside cardiologist Alain Cribier, MD, who successfully implanted the world¿s first transcather heart valve in 2002. He and fellow interventional cardiologist, Peter Block, MD, and cardiac surgeons, Vinod Thourani, MD, and Robert Guyton, MD, led the Edward LifeSciences trial at Emory.

"We are excited to be taking a multi-disciplinary approach to the treatment of aortic stenosis," says Thourani, an associate professor of surgery and the Emory co-principal investigator with Babaliaros.

"By offering a range of treatment options at Emory - from this transcatheter procedure to minimally-invasive surgical techniques - we are keeping our patients from Atlanta and all over the Southeast at the forefront of innovative technologies," adds Thourani.

Thourani and the Emory team of researchers recently hit their own milestone when they performed their 200th TAVI procedure. During the study, Emory was one of the highest volume centers participating in the clinical trial.

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