CERC has started to implement the Colibri Heart Valve CE mark trial. This balloon-expandable THV was designed with an original leaflet geometry and material enabling a reduction in the mass of cusps with the potential benefit of a larger effective orifice area even in out-of-round shapes of the frame.
In combination with proprietary dry tissue preparation, this allows for a pre-mounted, pre-packaged, low profile (true 14F) delivery system. This company-sponsored trial will be conducted in ten centers in four European countries in order to enrol 60 patients with a 1-year primary endpoint and 5-year clinical and echographic follow-up.