NewYork-Presbyterian Hospital/Columbia University Medical Center today became the first in the United States to implant the SAPIEN transcatheter aortic heart valve as an FDA-approved standard of care. This major advance in patient care follows the FDA's decision on Nov. 2 to approve SAPIEN as a preferred treatment for patients too sick to undergo traditional aortic valve surgery.
The recent FDA approval was based on results of the 26-center Placement of AoRTic TraNscathetER Valve (PARTNER) clinical research trial co-led by Drs. Martin Leon, Jeffrey Moses and Craig Smith at NewYork-Presbyterian/Columbia. Since the start of FDA-approved clinical trials in 2005, the Medical Center has performed more than 300 valve procedures - the most in the country.
NewYork-Presbyterian/Columbia physicians Drs. Susheel Kodali and Mathew Williams will also lead a live demonstration of the procedure on Nov. 9 at the annual TCT meeting in San Francisco. Going forward, the Medical Center will be one of only four sites to train American physicians in the procedure.
"Approval of the SAPIEN transcatheter aortic heart valve is a monumental event on par with FDA approval of the bare metal stent in 1994. For patients too sick for open-heart surgery, this new treatment is the difference between life and death," says Dr. Leon, director of the Cardiovascular Interventional Therapy (CIVT) Program at NewYork-Presbyterian Hospital/Columbia University Medical Center and professor of medicine at Columbia University College of Physicians and Surgeons. "It is a huge honor for our team to perform the first procedure as an FDA-approved preferred treatment."
"This achievement is born of an unprecedented collaboration between surgery and interventional cardiology. The aptly named PARTNER trial has not only demonstrated the benefits of the transcatheter aortic valve, but it has also presented a new model for research and clinical practice," says Dr. Smith, chairman of the Department of Surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center and the Johnson & Johnson Distinguished Professor and the Valentine Mott Professor of Surgery at Columbia University College of Physicians and Surgeons.
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