Edwards Lifesciences (NYSE:EW) announced today 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 facilitate 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 a news release.
Edwards touted early clinical evidence of procedural success and clinical improvements, with Pascal demonstrating sustained TR reduction at 30 days. The company is conducting the Clasp II TR pivotal study to investigate Pascal in patients with symptomatic functional or degenerative TR, as well as the Triscend study for the Evoque system for tricuspid valve replacement.
Pascal is not yet approved in the U.S. It did receive CE Mark approval for treating mitral regurgitation in February 2019.
“Patients with tricuspid valve disease are in great need of solutions,” Edwards corporate VP of transcatheter mitral & tricuspid therapies Bernard Zovighian said in the release. “Edwards is the first company to introduce multiple transfemoral tricuspid repair therapies in Europe, providing physicians with both leaflet repair and annular reduction therapies to help meet their patients’ needs.”
Last month, the TriClip transcatheter tricuspid valve repair system from Abbott (NYSE:ABT) won CE Mark approval. The company touts it as the first minimally invasive, clip-based tricuspid valve repair device in the world to be made commercially available.
