Bethlehem, PA (August 29, 2012) – St. Luke's University Hospital - Bethlehem surgeons successfully performed their fourth Transcatheter Aortic Valve Replacement (TAVR) case yesterday and were approved by Edwards Lifesciences -- the global leader in heart valve sciences, to provide the procedure without a proctor facility. According to Raymond A. Durkin, MD, chief of Cardiology for St. Luke's University Health Network, this means St. Luke's specially trained surgeons can now schedule and perform these ground breaking cases on their own. For patients who have been deemed inoperable for traditional open-heart surgery, this new procedure called transcatheter aortic valve replacement (TAVR) is now available as a treatment option. This new transcatheter procedure allows the diseased heart valve to be replaced without open-heart surgery.
"This is one of the true paradigm changing treatments of heart disease we will see in our lifetimes," says Dr. Durkin, "and at present, being able to do it independently carries significant status and responsibility. We want to use this status in the community to increase our efforts to treat not only valvular heart disease but all heart disease in general."
In November of 2011, the U.S. Food and Drug Administration (FDA) approved the Edwards SAPIEN Transcatheter Heart Valve for the treatment of patients with severe symptomatic native aortic valve stenosis. The Edwards SAPIEN Valve is the first transcatheter aortic valve replacement (TAVR) therapy approved for use in the United States. Select hospitals, including St. Luke's University Hospital – Bethlehem, are now performing the procedure on qualified patients.
The U.S. Food and Drug Administration (FDA) has approved TAVR for high risk patients in addition to its original use (for traditionally inoperable patients).
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