Edwards gets U.S. clearance for PASCAL tricuspid repair indication
The U.S. Food and Drug Administration authorized Edwards Lifesciences’ PASCAL Precision device on Oct. 21 for transcatheter repair of tricuspid valves. The indication covers symptomatic patients with severe tricuspid regurgitation who remain symptomatic after medical treatment and face intermediate or greater surgical risk. The FDA also cleared Edwards’ PASCAL Ace with Capture Clarity system for degenerative mitral valve repair procedures.
Why it matters
The decision expands the patient population addressable by Edwards’ transcatheter valve portfolio and gives the company repair and replacement options for both mitral and tricuspid valves in the U.S. Edwards says it is the only U.S. company with that combination of offerings.
Key facts
- 1The FDA granted the PASCAL Precision tricuspid repair indication on Oct. 21. ocbj.com
- 2Eligible patients must have symptomatic severe tricuspid regurgitation despite optimal medical therapy and be assessed as having intermediate or higher surgical risk. medicaldevice-network.com
- 3The FDA also cleared PASCAL Ace with Capture Clarity for degenerative mitral transcatheter edge-to-edge repair procedures. rttnews.com
- 4Edwards said the approval makes it the sole U.S. provider of transcatheter repair and replacement therapies for both mitral and tricuspid valves. medicaldevice-network.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.