Data to Be Presented for Valtech Cardio's Cardioband Annuloplasty System

March 9, 2015­—Valtech Cardio, Ltd. announced that it will present updated results of its multicenter feasibility study of the Cardioband annuloplasty system at ACC.15, the American College of Cardiology scientific sessions being held March 14–16, 2015 in San Diego, California. The data include the initial 1-year follow-up of 10 patients treated with the Cardioband, a transcatheter adjustable mitral annuloplasty system for patients with functional mitral regurgitation (MR). The Cardioband system enables percutaneous implantation of an adjustable “surgical-like” mitral annuloplasty ring using a transseptal approach.

Georg Nickenig, MD, from the Department of Cardiology at the University Hospital Bonn in Bonn, Germany, will present “Percutaneous Mitral Valve Direct Annuloplasty With a ‘Surgical-Like’ Ring: Results From Multicenter First-in-Man Feasibility Trial” in room 11A at 9:15 am on Monday, March 16.

European CE Mark approval is expected soon for the device, which has shown considerable promise as a safe, efficacious, and doable intervention option for functional MR patients, advised Valtech Cardio.

According to Valtech Cardio, the objective of the study was to evaluate the feasibility, safety, and performance of a Cardioband in patients with functional MR. The investigators enrolled 35 high-risk patients with significant functional MR at five sites in Europe between February 2013 and January 2015. After a heart team evaluation, all patients were screened by echocardiography and cardiac CT to assess feasibility. Echocardiographic data were analyzed by an independent core laboratory.

The investigators concluded that transseptal direct mitral annuloplasty with an adjustable “surgical-like” ring is feasible with a good safety profile. They observed that effective reduction in MR severity in most patients related to a significant septolateral dimension reduction. MR reduction was stable and consistent at 1 year with clinical benefit.

In the company’s announcement, Dr. Nickenig commented, “We have extremely convincing results with the treatment of 10 patients thus far. Cardioband has proven its efficacy by significantly reducing MR in each patient. In addition, its safety profile is also proven and this is true for centers across the board. Cardioband is a very exciting, innovative, and novel technique.”

The Cardioband system combines an annuloplasty implant, similar to the surgical annuloplasty devices, 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 for optimal results, stated the company.