Edwards Lifesciences Corporation, global patient-focused innovations for structural heart disease and critical care monitoring, announced that it has received CE Mark for the Edwards PASCAL transcatheter valve repair system for the treatment of European patients with tricuspid regurgitation (TR).
"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," said Prof. Jörg Hausleiter, MD, Medizinische Klinik der Ludwig-Maximilians-Universität München in Munich, Germany. "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."
The PASCAL system is indicated in Europe for the percutaneous reconstruction of the tricuspid valve through leaflet repair by tissue approximation. 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 optimized leaflet capture and the implant can be elongated to a narrow profile, allowing for safe maneuvering in dense chordal anatomy.
"Patients with tricuspid valve disease are in great need of solutions," said Bernard J. Zovighian, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "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."
In early clinical experience, the PASCAL repair system demonstrated high procedural success and significant clinical improvements in patients with challenging tricuspid anatomy and severe TR. Sustained TR reduction was observed at 30 days, with 85 percent of patients seeing a reduction to TR ≤2+ on a five-grade scale.
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 TR, 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 TR patients in Europe is focused on procedural success and differentiated patient outcomes, with a high-touch clinical support model.
The PASCAL repair system is not approved in the United States.
Prof. Jörg Hausleiter is a consultant for Edwards and a member of its Advisory Board, receiving compensation for services including proctoring, educational presentations, expert advice and R&D insights, as well as associated travel.
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