Occlutech Obtains European CE Approval for its Dedicated Paravalvular Leak Closure Device
JENA, Germany, September 30, 2014 /PRNewswire/ —
Occlutech, a leading innovator of products to treat structural heart disease today 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.
About Paravalvular Leaks
Paravalvular leaks (PVLs) are a significant complication after valve replacement. 1% to 5% of patients undergoing mitral or aortic valve replacements experience PVLs of various severities, ranging from asymptomatic and benign to life-threatening. Depending on leak size, regurgitation can cause congestive heart failure and pulmonary edema, can increase the risk for endocarditis, and often provokes mild to substantial, transfusion-requiring hemolysis.
Occlutech is a global leader in developing innovative products for the treatment of structural heart disease. The Company sells and markets ASD, PFO, PLD and PDA occluders, as well as a range of specialized occlusion devices and accessories in well over 80 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at http://ift.tt/1uWdtGK .
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