Israel-based Valtech Cardio has received CE Mark approval for its Cardioband Mitral Reconstruction System (Cardioband), an implantable mitral reconstruction device with a transfemoral transseptal delivery system for mitral valve repair.
Cardioband is a combination of reconstruction implant, similar to surgical annuloplasty devices, with a transfemoral transseptal delivery system.
In mitral regurgitation (MR), mitral valve leaflets fail to close properly, allowing backflow of blood from the left ventricle into the left atrium during systole.
Approval was based on results of a multicentre feasibility trial that showed the safety and effectiveness of Cardioband in mitral valve repair and will allow the company to market and sell the system in the EU.
More than 50 patients were included in the trial, in which Cardioband was shown to significantly reduce annular size, with improvement in MR.
The product will be unveiled at the upcoming PCR London Valves meeting in Berlin, Germany.
Valtech Cardio founder Amir Gross said: "The Cardioband was specifically designed to facilitate mitral valve repair in a first-line setting while preserving the ability to perform future percutaneous or surgical valve repair and/or replacement, and the results of our multicenter clinical trial really help to demonstrate the success of this device in this indication."
If left untreated, severe MR can eventually lead to a meaningful deterioration in cardiac function and, eventually, death.
In the US, 4.2 million patients are affected by mitral valve disease, which represents a significiant market opportunity.
Cardioband allows surgical-like repair of the mitral valve annulus via a transfemoral, transseptal delivery system, allowing for real-time adjustment on a beating heart.
The company noted the transcatheter, supra-annular approach does not interfere with the mitral valve leaflets or chordae, and does not preclude subsequent treatment options if they become necessary.