News | October 07, 2014

Occlutech Obtains European CE Approval for its Dedicated Paravalvular Leak Closure Device

Occlutech CE mark Dedicated Paravalvular Leak Closure Device

October 7, 2014 — Occlutech announced that it has obtained a European CE mark approval for its dedicated Paravalvular Leak Closure Device (PLD). The implant is the world´s first, specifically designed device indicated for the minimally invasive closure of leaks occurring around artificial aortic and mitral valves.

Tor Peters, CEO of the Occlutech Group, commented: "We are extremely pleased to provide patients and cardiologists with this innovative product and expect our PLD to save and significantly prolong lives in this growing patient population."

Occlutech's PLD consists of a flexible nitinol wire mesh with "shape-memory" properties. The implant is available in different configurations, multiple sizes and can accommodate a broad range of paravalvular leak anatomies. With an ageing population requiring increasingly more valve replacement surgeries, the frequency of paravalvular leaks is increasing. The Occlutech PLD implant allows atraumatic, minimally invasive closure of paravalvular leaks. PVL closure using implantable devices is in many cases the only alternative available for patients who are too weak to undergo repeat valve replacement or cardiac surgery.

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