Germany-based Occlutech has obtained CE mark approval for its Paravalvular Leak Closure Device (PLD).
The device has been developed for the minimally invasive closure of leaks occurring around artificial aortic and mitral valves.
Occlutech Group CEO Tor Peters said: "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."
The device includes flexible nitinol wire mesh, and is available in different configurations and multiple sizes. It can accommodate a wide range of paravalvular leak anatomies.
Occlutech noted that PLD implant allows atraumatic, minimally invasive closure of paravalvular leaks.
Paravalvular leaks (PVLs) are a significant complication after valve replacement, and up to 5% of patients undergoing mitral or aortic valve replacements experience PVLs of various severities, ranging from asymptomatic and benign to life-threatening.
Occlutech, which operates facilities in Germany, Turkey and Sweden, also sells and markets ASD, PFO and PDA occluders.