Edwards Lifesciences has announced that its Pascal transcatheter valve repair system for treating tricuspid regurgitation (TR) has received CE Mark approval.
Pascal offers percutaneous reconstruction of the tricuspid valve through leaflet repair by tissue approximation. The system utilises clasps and paddles to hold leaflets and facilitate coaptation. A spacer fills the regurgitant orifice area and prevents backflow.
The Pascal system’s clasps can be independently operated, facilitating optimised leaflet capture, and the implant can be elongated into a narrow profile, allowing for safe manoeuvring, the company says.
While the Pascal system has not yet been approved by the USA’s FDA, Irvine, California-based Edwards Lifesciences said the system has demonstrated procedural success as well as clinical improvements in patients with TR.
Sustained reduction in TR was observed after 30 days, with 85 per cent of patients seeing a reduction to TR ≤2+ on a five-grade scale.
Edwards Lifesciences corporate vice-president Bernard J. Zovighian commented: "Patients with tricuspid valve disease are in great need of solutions. 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."
Pascal received CE Mark approval for the treatment of mitral regurgitation in February of last year.