News | March 26, 2015

Edwards' CEO Addresses Senate Committee on Preserving, Strengthening U.S. Medical Device Innovation

Comments highlight improved collaboration, need to reduce regulatory and financial barriers

March 26, 2015 — Edwards Lifesciences Corp. announced that chairman and CEO Michael A. Mussallem served as an invited expert panelist on behalf of the Advanced Medical Technology Association (AdvaMed) at the United States Senate Health, Education, Labor and Pensions Committee hearing on "Continuing America's Leadership: Advancing Research and Development for Patients."

"As medical technology innovators, it's our passion and mission to continue developing better solutions to improve the lives of patients," said Mussallem.  "To maximize the impact of this work, it is imperative that we forge a path toward revitalizing the medical technology ecosystem in the United States. Continued innovation is vital to improving clinical outcomes, enhancing patients' quality of life and bringing increased value to the healthcare system."

Mussallem noted collaborative engagement and significant progress by the U.S. Food & Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) in better understanding and improving the predictability and approval timelines for future generations of medical devices.

He also addressed opportunities to further reduce barriers in regulatory approval and reimbursement, in order to help promote America's continued worldwide leadership in medical device development and also to support innovation. His comments focused on three primary areas:

  • the acceleration of FDA's vision to improve the regulatory process;
  • the need to strengthen the research and development infrastructure so it is second to none; and
  • continued encouragement of innovation by addressing issues throughout the entire ecosystem.


Mussallem also drew upon Edwards' experience with the Sapien transcatheter aortic heart valves to discuss the current regulatory environment in the United States.

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