Monday, September 14, 2015
Valtech Cardio, Ltd., a developer of devices for mitral and tricuspid valve repair and replacement, said it has received Conformite Europeenne Marking for its Cardioband Mitral Reconstruction System, a proprietary, implantable mitral reconstruction device with a transfemoral, transseptal delivery system for mitral valve repair.
The designation, received from Dekra, Valtech's notified body in the European Union, was based on the results of a multicenter feasibility trial that demonstrated the safety and effectiveness of Cardioband in mitral valve repair. This will allow Valtech to market and sell the device in the European Union.
Results of the study demonstrated that Cardioband is a highly effective first-line treatment option for reducing mitral regurgitation and improving quality of life scores.
Funded in part from investments made by HeartWare International, Inc. ( HTWR ) and other private investors, Valtech is headquartered in Or Yehuda, Israel.
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