FDA Advisory Panel Gives Nod to Pre-Market Approval of the Transcatheter Heart Valve
On June 13, the U.S. Food and Drug Administration’s (FDA’s) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 11 -0 with one abstention in favor of expanding indications for use of the Edwards SAPIEN™ Transcatheter Heart Valve to include patients eligible but at high risk for aortic valve surgery and the transapical approach.
The Sapien system was previously approved last November for patients who are not considered surgical candidates for aortic valve replacement. The advisory panel’s decision follows a day-long hearing that included testimonies from representatives from the ACC, The Society of Thoracic Surgeons (STS), Edwards Lifesciences, the FDA, patients and physicians.
John Carroll, MD, FACC, from the University of Colorado, Denver, and a member of STS/ACC Transcatheter Valve Therapy (TVT) Registry Steering Committee, testified on the College’s behalf. His testimony focused on how registries like the STS/ACC TVT Registry can be leveraged to evaluate patient selection, procedure indications, peri-procedural outcomes and longitudinal safety surveillance and patient outcomes. He also discussed the benefits to using a clinical registry for post-market surveillance and specifically using the recently created TVT Registry for post approval studies, which include:
- Ability to focus on previously identified critical issues
- Development of risk models tailored for the TVT population
- Tracking of long-term and quality of life outcomes
- Decision-making tools for patients, families, clinicians and regulators
- Appropriateness of care
- Potential expansion of indications for use
Dr. Carroll followed a presentation from Jeffrey Rich, MD, FACC, president of STS, on the collaboration of cardiologists and surgeons in bringing transcatheter aortic valve replacement (TAVR) to the American population.
The hearing concluded with votes on three final questions:
- Is there reasonable assurance that the Edwards SAPIEN Transcatheter Heart Valve is safe for use in patients who meet the criteria specified in the proposed indication? The panel voted 10-2.
- Is there reasonable assurance that the Edwards SAPIEN Transcatheter Heart Valve is effective for use in patients who meet the criteria specified in the proposed indication? The panel voted 12-0.
- Do the benefits of the Edwards SAPIEN Transcatheter Heart Valve for use in patients who meet the criteria specified in the proposed indication outweigh the risks for use in patients who meet the criteria specified in the proposed indication? The panel voted 11-0-1.
It is now up to the FDA to make a final decision. More information will be available on CardioSource as it becomes available, including exclusive video coverage. Read the ACC's complete written testimony here.
In addition, the ACC and STS are holding a webinar, along with the Centers for Medicare and Medicaid Services (CMS), on Thursday, June 21 at noon ET. The webinar will focus on the recent CMS national coverage decision on TAVR, including heart team and hospital qualification requirements, and the STS/ACC TVT Registry.
< Back to Listings