Edwards Lifesciences Pascal
Edwards Lifesciences (NYSE:EW) announced May 18 that it received CE Mark approval for its Pascal transcatheter valve repair system for treating tricuspid regurgitation (TR).
Pascal won its indication in Europe for the percutaneous reconstruction of the tricuspid valve through leaflet repair by tissue approximation. The device uses clasps and paddles to grasp the leaflets and enable coaptation, while the spacer is designed to fill the regurgitant orifice area and prevent backflow.
The clasps can be operated independently to facilitate optimized leaflet capture and the implant can then be elongated to a narrow profile to allow for safe maneuvering in dense chordal anatomy, according to Edwards.