Six-Month Data Presented for Valtech Cardio's Cardioband Annuloplasty System

February 12, 2015—Valtech Cardio, Ltd., developer of the Cardioband annuloplasty system, today announced that updated 6-month follow-up results of 20 patients in their multicenter feasibility study will be presented at JIM 2015: the Joint Interventional Meeting, which is being held in Rome, Italy on February 12–14.

Cardioband is a transcatheter adjustable mitral annuloplasty system for patients with functional mitral regurgitation (FMR). The company stated that it is expecting to receive European CE Mark approval for the Cardioband, which has demonstrated promise as a safe and efficacious intervention option for FMR patients.

According to Valtech, 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 mitral regurgitation is done under physiological conditions and echocardiographic guidance for optimal results.

The device’s first user, Francesco Maisano, MD, commented in the company’s press release, “The future of FMR treatment lies in the repair-and-replace paradigm. Mitral regurgitation repair with Cardioband can be the first-line therapy for severe mitral regurgitation 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.” Dr. Maisano is Chairman and Professor of Cardiovascular Surgery at the University Hospital Zurich in Switzerland.

According to the company, the Cardioband system is designed as a first-line interventional therapy that preserves the option for future percutaneous or surgical solutions, including clip or neochord secondary or valve-in-ring replacement. The Cardioband, which is delivered via a transfemoral delivery system, has been clinically proven to cause significant annulus anatomy change followed by significant reduction in mitral regurgitation, as shown in the results of the multicenter feasibility trial presented at the JIM 2015 meeting.

At the meeting, Karl-Heinz Kuck, MD, from the Department of Cardiology at Asklepios Klinik St. George in Hamburg, Germany, is presenting the study, “Transcatheter Annuloplasty With the Cardioband: Surgical Efficacy Delivered With Safety.”

As summarized by the company, the multicenter study’s objective is to evaluate the feasibility, safety, and performance of a transcatheter adjustable mitral annuloplasty system in patients with FMR.

The study enrolled 30 high-risk patients with significant FMR at five sites in Europe between February 2013 and November 2014. 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. Effective reduction in mitral regurgitation severity is observed in most patients related to a significant septolateral dimension reduction. Mitral regurgitation reduction is stable and consistent at 6 months with clinical benefit, reported the company.