Valtech Presents Feasibility Data on Cardioband Annuloplasty System

May 21, 2015—Valtech Cardio, Ltd., presented updated results of its multicenter feasibility study of the Cardioband Annuloplasty System at the EuroPCR conference, which took place May 19–22 in Paris, France. Cardioband is about to receive its CE Mark, the company stated in its press release.

The study included follow-up of 40 patients. In this trial, the technology was shown to cause significant annulus anatomy change and significant reduction in mitral regurgitation (MR). At 6-month follow-up (n = 21), 80% of patients were in NYHA class I–II, with significant improvement of quality of life (MLWHFQ from score of 38 to 18; P < 0.05, and 6 MWT from 248 to 322; P < 0.01). At 12-month follow-up (n = 14), 93% of patients were with MR ≤ 2+.

The Cardioband system combines an annuloplasty implant with a transfemoral venous delivery system. Connection of the implant to the mitral annulus is sutureless using specially designed anchors. Reshaping of the mitral annulus to eliminate MR is done under physiological conditions and echocardiographic guidance.

“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,” commented Francesco Maisano, MD, first user of the Cardioband procedure and Chairman and Professor of Cardiovascular Surgery at the University Hospital Zurich in Zurich, Switzerland, in the company’s press release.