February 12th, 2013
ACC and STS Break New Ground to Test TAVR for Unapproved Uses
Larry Husten, PHD
In a startling break with tradition, the American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such […]
June 27th, 2011
TAVI: Playing in the Sandbox Together
Richard A. Lange, MD, MBA and L. David Hillis, MD
Kudos to the the American College of Cardiology Foundation (ACCF) and the Society of Thoracic Surgeons (STS) for getting ahead of the game by rolling out a joint position statement regarding transcatheter aortic valve implantation (TAVI) before the FDA panel convenes in July to consider approval of the procedure. It’s a terrific first step to avoid some of the […]