Edwards Lifesciences has received the CE mark for the PASCAL transcatheter valve repair system for the treatment of European patients with tricuspid regurgitation.
A press release reports that the PASCAL system is indicated in Europe for the percutaneous reconstruction of the tricuspid valve through leaflet repair by tissue approximation. It adds that the clasps and paddles gently grasp the leaflets to facilitate coaptation, while the spacer is designed to fill the regurgitant orifice area and prevent backflow.
The clasps can be operated independently to facilitate optimised leaflet capture and the implant can be elongated to a narrow profile, allowing for safe manoeuvring in dense chordal anatomy. In early clinical experience, according to the press release, the PASCAL repair system demonstrated high procedural success and significant clinical improvements in patients with challenging tricuspid anatomy and severe tricuspid regurgitation. Sustained tricuspid regurgitation reduction was observed at 30 days, with 85% of patients seeing a reduction to tricuspid regurgitation ≤2+ on a five-grade scale.
The press release reports that Edwards continues to build a body of clinical evidence for transfemoral tricuspid therapies, including with the CLASP II TR pivotal study investigating the PASCAL system in patients with symptomatic functional or degenerative tricuspid regurgitation the TRISCEND study investigating the EVOQUE system for tricuspid valve replacement, as well as real-world experience. The launch of the PASCAL system for the treatment of tricuspid regurgitation patients in Europe is focused on procedural success and differentiated patient outcomes, with a high-touch clinical support model.
Jörg Hausleiter ( Medizinische Klinik der Ludwig-Maximilians-Universität München, Munich, Germany) says: “Although the prevalence of tricuspid valve disease and the associated mortality are high, there are limited effective treatment options for these very symptomatic patients, who often cannot have surgery due to the prohibitive risk. Transcatheter tricuspid therapy can be challenging due to the fragile leaflets and the large defects during valve closure. In our experience, the PASCAL system’s independent grasping ability as well as the flexible and less traumatic clasp design are important features for our patients.”