Valtech's Cardioband Mitral Reconstruction System Receives CE Mark Approval for TMVR

September 14, 2015—Valtech Cardio, Ltd. announced that it has received European CE Mark approval for its Cardioband mitral reconstruction system, which is an implantable device with a transfemoral, transseptal delivery system for transcatheter mitral valve repair (TMVR). Valtech will introduce the Cardioband device at the PCR London Valves meeting, which is being held September 20–22, 2015, in Berlin, Germany. 

According to the company, the approval was based on the results of a multicenter feasibility trial that demonstrated the safety and effectiveness of the Cardioband in TMVR for patients with functional mitral regurgitation (MR). In the trial, which was composed of more than 50 patients, Cardioband was shown to significantly reduce annular size, with significant improvement in MR. At 6-month follow-up, 82% of patients (n = 22) were categorized in New York Heart Association class 1 to 2, with significant improvement in quality-of-life (Minnesota Living With Heart Failure Questionnaire) score of 38 to 18 (P < .05) and had a 6-minute walk test score of 250 to 322 (P < .05). At 12-month follow-up, 94% of patients (n = 17) had sustained MR of ≤ 2+. 

The Cardioband system combines a reconstruction implant, similar to the surgical annuloplasty devices, with a transfemoral, transseptal 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 performed under physiological conditions and echocardiographic guidance for optimal results. The transcatheter, supra-annular approach with Cardioband does not interfere with the mitral valve leaflets or chordae and does not preclude subsequent treatment options if they become necessary, noted the company.

Francesco Maisano, MD, who is Chairman and Professor of Cardiovascular Surgery at The University Hospital of Zurich in Zurich, Switzerland, performed the first Cardioband procedure.

In the company’s press release, Dr. Maisano commented, “The future of functional MR treatment lies in the repair-and-replace paradigm. 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.”

Valtech, an Israel-based company developing surgical and transcatheter valve repair and replacement devices for the treatment of MR and tricuspid valve regurgitation, has a product portfolio that includes the Cardioband, Cardinal, CardioValve, and V-Chordal devices. On September 2, HeartWare International, Inc. announced that it has entered into a definitive agreement to acquire Valtech Cardio.