CEO Addresses Senate Committee

Michael A. Mussallem Chairman and CEO of Edwards Lifesciences appeared before the Senate Committee on Health, Education, Labor and Pensions on behalf of the association AdvaMed on March 26th. He gave his unique perspective on how his company has developed devices to help people suffering from a deadly heart valve disease called aortic stenosis.

The Edwards SAPIEN transcatheter aortic heart valves delivers a collapsible prosthetic valve into the body via a catheter-based delivery system. The valve is designed to replace a patient’s diseased native aortic valve while the heart continues to beat. Some patients who receive the SAPIEN Transcatheter Aortic Valve Replacement (TAVR) can leave the hospital and return home the next day.

Mussallem told the Committee that his company was encouraged to see that FDA is bringing newer generations of TAVR products to patients faster and as a result, the device lag for TAVR has narrowed significantly.

Under the TAVR national coverage determination, CMS requires that every U.S. patient be enrolled in a qualified prospective registry that tracks appropriate outcomes data to the patient level.

In a collaboration between medical societies, regulators, and other interested stakeholders, the American College of Cardiology and the Society of Thoracic Surgeons helped to build what is referred to as the STS/ACC TVT Registry.

The registry has really helped FDA improve the process to reduce device lag approval since FDA has access to the registry data. Data from the STS/ACC TVT Registry used by FDA in 2013 helped to expand the indications for use of the SAPIEN technology, allowing access to a broader patient population.  Today, as new patient populations are approved, they are immediately covered by Medicare.

Mussallem realizes that TAVR is a unique example of a breakthrough technology that has been helped by attention from FDA and CMS. As he said, “If these techniques can be applied to other technologies more broadly, that would go a long way towards revitalizing innovation in the U.S.”

Go to to read the full transcript.


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