FDA approves aortic heart valve for inoperable patients
Beaumont is the only hospital in Michigan to replace heart valves with recently FDA-approved device.
The FDA approved the transfemoral (through the femoral artery in the leg) delivery of the Edwards SAPIEN transcatheter aortic heart valve for the treatment of inoperable patients with severe symptomatic aortic stenosis. This valve is the first United States commercial approved transcatheter device enabling aortic valve replacement without the need for open-heart surgery. Beaumont, Royal Oak was the first hospital in North America to replace heart valves with this transcatheter device in 2005. Currently, Beaumont is the only hospital in Michigan that can use this valve with a transcatheter approach. Beaumont had a pivotal role in the valve being approved by the FDA by introducing the technology to the United States after having an opportunity to watch this procedure being performed in France in 2004.
This transcather approach to aortic valve replacement is the latest addition to our minimally invasive heart and vascular surgery program. If patients are too high-risk for aortic valve replacement through a chest incision, the transfemoral approach can be used in almost all other cases, stated Francis Shannon, M.D., Beaumont cardiovascular surgeon and a co-investigator in the trial.