Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, announced that Edwards' Chairman and CEO Michael A. Mussallem today served as an expert panelist at the invitation of the United States Energy and Commerce Committee's Subcommittee on Health to discuss medical device innovation at its hearing, "21st Century Cures: Examining Barriers to Ongoing Evidence Development and Communication."
"Edwards has five decades of experience in developing and delivering new therapies to American patients, and we are concerned about the alarming and documented decline in U.S. medical innovation," said Mussallem. "We identified areas of improvement that we believe can support a balanced ecosystem, which welcomes innovations to enable patients to live longer, healthier lives."
Mussallem noted the constructive and collaborative relationship with the Food and Drug Administration and the Centers for Medicare & Medicaid Services and identified three primary areas of improvement to promote America's leadership in medical device development, and ensure delivery of new treatments to patients around the world:
- Evidence development mechanisms can be improved to reduce costs and delays.
- Economic incentives need to be aligned with promoting innovation.
- FDA's vision to improve the regulatory process must be accelerated.
Mussallem drew on Edwards' experience with the SAPIEN transcatheter aortic heart valves to discuss the regulatory and reimbursement challenges and opportunities in the U.S. His full written comments can be read at http://energycommerce.house.gov/hearing/barriers-ongoing-communication-and-evidence-development. To learn more about the hearing or view a webcast of the event, visit the Energy and Commerce Committee's website at http://energycommerce.house.gov/studio/webcasts.