Israel-based Valtech Cardio has received CE mark approval for its Cardioband Mitral Reconstruction System, an implantable mitral reconstruction device with a transfemoral and transseptal delivery system for mitral valve repair.
The approval has been secured from the firm’s notified body in the European Union (EU), Dekra, based on the results of a multicenter feasibility trial that showed the safety and effectiveness of Cardioband in mitral valve repair.
Cardioband aggregates a reconstruction implant, similar to the annuloplasty devices, with a transfemoral, transseptal delivery system. The specially designed anchors allows in sutureless connection of the implant to the mitral annulus.
Valtech founder and CEO Amir Gross said: "Receipt of the CE mark is the culmination of concerted and concentrated efforts by many individuals, and it is the result of productive collaboration with the medical community."
According to the firm, the results demonstrated that Cardioband is an effective first-line treatment option for reducing mitral regurgitation (MR) and improving quality of life scores.
Valtech’s multicenter feasibility trial included around 50 patients, in which Cardioband was shown to significantly reduce annular size, with better improvement in MR.
Cardioband allows surgical-like repair of the mitral valve annulus through a transfemoral and transseptal delivery system, helping in adjustment on a beating heart.
The transcatheter and supra-annular approach does not intervene with the mitral valve leaflets or chordae, as well as does not preclude subsequent treatment options if they become necessary.
The company will exhibit the Cardioband at the PCR London Valves meeting in Berlin, which will be held from 20 to 22 September.