FDA Update: Transcatheter System For Degenerative Mitral Regurgitation Approved

The U.S. Food and Drug Administration (FDA) has approved Edwards Lifesciences Corporation’s Pascal Precision system for treatment of transcatheter edge-to-edge repairs (TEER) in patients with degenerative mitral regurgitation (DMR).

According to Edwards’ press release, the system provides “safe and effective treatment for patients with DMR” and “is designed for maneuverability and stability, enabling precise navigation and implant delivery.”

Data from the CLASP IID trial, which compares two contemporary TEER therapies, will be presented as late-breaking clinical science on Sept. 17 during TCT 2022.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Mitral Regurgitation

Keywords: Heart Valve Prosthesis Implantation, Mitral Valve, United States Food and Drug Administration, Mitral Valve Insufficiency

< Back to Listings