Annuloplasty System Promotes Mitral Valve Repair

The mitral annulus is reshaped under echocardiographic guidance for real-time adjustment on the beating heart, thus delivering optimal MR reduction results. 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.

In a multicenter feasibility trial that included more than 50 patients, Cardioband was shown to significantly reduce annular size, with significant improvement in MR. After six months of follow-up, 82% of the patients were categorized in NYHA Class I-II, with significant improvement of Minnesota quality of life and six-minute walk test scores. The Cardioband mitral reconstruction system is a product of Valtech Cardio (Or Yehuda, Israel), and has received the CE marking of approval.

“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,” said Amir Gross, founder and CEO of Valtech. “We are confident that Cardioband will prove to be a meaningful addition to physician's available treatment options in addressing MR, providing a first-line mitral valve repair option that preserves the ability to perform future percutaneous or surgical valve repair and replacement.”

“The future of functional mitral regurgitation treatment lies in the repair-and-replace paradigm,” said Francesco Maisano, MD, first user of the Cardioband procedure and chairman and a professor of cardiovascular surgery at The University Hospital of Zurich (Switzerland). “MR repair with Cardioband can be the first-line therapy for severe MR patients. Additionally, early-stage repair can support ventricular reverse remodeling while keeping the options open for the patient, supporting the technology's use at earlier stages.”

FMR is considered a disease of the left ventricle, not of the mitral valve, occurring when the left ventricle of the heart is distorted or enlarged, thus displacing the papillary muscles that support the two valve leaflets and stretching the annulus. Since the valve leaflets can no longer come together to close the annulus, blood flows back into the atrium. If left untreated, FMR overloads the heart and can lead to or accelerate heart failure.

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