First-in-Human Implantation Performed With MValve's Transapical Mitral Valve Replacement System

October 5, 2015—MValve Technologies Ltd. announced the first-in-human implantation of its catheter-based transapical mitral valve replacement system. The procedure was conducted at the University Clinic in Bonn, Germany.

The MValve transcatheter docking device was implanted successively in combination with the Lotus transcatheter heart valve (Boston Scientific Corporation). Postoperative imaging confirmed the valve was positioned perfectly and functioning well with no residual regurgitation, reported the company.

According to the company, the procedure was performed in a 72-year-old man with a long history of valve disease. The patient had undergone surgical aortic valve replacement several years previously, and recently his diseased mitral valve began to fail with worsening regurgitation in the setting of severe mitral annular calcification. Because of the patient’s general cardiac status, unfavorable mitral valve anatomy, and overall frailty, he was deemed inoperable by the local heart team.

Present at the procedure were Prof. Georg Nickenig, MD, an interventional cardiologist and Director of the University Clinic; Prof. Eberhard Grube, MD, who is Director of the Center for Cardiac Innovation; Prof. Armin Welz, MD, Director of Cardiovascular Surgery; Wolfgang Schiller, MD, a cardiothoracic surgeon; and Christoph Hammerstingl, MD, an echocardiology specialist. 

In the company’s press release, Prof. Grube commented, “We are grateful to have had the opportunity to work with the MValve team in order to provide treatment for this particular patient in whom no other alternatives were available.”

Professor Nickenig added, “Given the particularly challenging anatomy with heavy calcification throughout and failed prior treatment attempts, neither mitral valve surgery nor other transcatheter therapies were possible.”

Interventional cardiologist Maurice Buchbinder, MD, who is founder and Medical Director of MValve, also attended the procedure. Dr. Buchbinder stated in the company’s announcement, “The MValve transcatheter mitral replacement system is a unique approach to mitral valve replacement therapy. The MValve docking device provides a secure platform within the mitral annulus, enabling the implantation of an approved transcatheter heart valve, such as the Lotus valve, in the native mitral position. This procedure in many ways mimics the valve-in-valve or valve-in-ring procedures currently performed in patients with degenerated previously implanted surgical prostheses.”

MValve Ltd. is a privately held company founded in 2011, with lead investment from Boston Scientific Corporation. The company operates from Herzeliya, Israel and San Diego, California.