One-Year Data Support Valtech's Cardioband Mitral Valve Reconstruction System

May 31, 2016—One-year follow-up results of a European study of the Cardioband mitral value reconstruction system (Valtech Cardio, Ltd.) were presented at the EuroPCR 2016 conference held May 17–20 in Paris, France.

According to the EuroPCR announcement, the system enables reconstruction of the mitral valve by direct annuloplasty delivered transfemorally with no need for open heart surgery. The presentation demonstrated that the Cardioband system reduces mitral regurgitation (MR) and improves functioning and quality of life in high-risk patients with significant secondary MR. The investigators enrolled 49 high-risk patients with significant secondary MR; 82% were in New York Heart Association (NYHA) heart failure class 3–4 with a mean left ventricular ejection fraction of 33%.

The investigators reported that the procedure was successful, with the device implanted and MR reduced to grade 2 or lower in 87% of patients (41/47). At 12-month follow-up, 89% of patients (n = 22) had MR grade 2 or lower, and 68% had NHYA heart failure class 1–2 and showed significant improvement in quality of life and exercise tolerance.

The investigation was led by Prof. Georg Nickenig, MD, of the University of Bonn in Bonn, Germany. In the EuroPCR press release, Prof. Nickenig commented, “Transeptal mitral repair with the Cardioband device resulted in reduction of MR by reconstruction of the mitral annulus. The safety profile is comparable to other transcatheter mitral procedures, and the reduction in severity of MR and clinical benefit are stable up to 12 months.”

In September 2015, Valtech, which is based in Yehuda, Israel, announced that the Cardioband system received European CE Mark approval after clinical trial results demonstrated that the device is a safe and efficacious intervention option for patients with functional MR.