MValve Technologies Implants First Human Catheter Based Mitral Valve Replacement System

HERZELIYA, Israel, October 5, 2015 /PRNewswire/ --

MValve Technologies Ltd announced today the first human implantation of its catheter based transapical mitral valve replacement system. The procedure was completed successfully at the University Clinic in Bonn, Germany.

The procedure was performed on a 72 year-old male with longstanding history of valve disease. The patient underwent surgical aortic valve replacement several years ago and recently his diseased mitral valve began to fail with worsening regurgitation in the setting of severe mitral annular calcification.

Given this 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 Professor Georg Nickenig (interventional cardiologist and Director of the Clinic), Professor Eberhard Grube (Director center for cardiac innovation), Professor Armin Welz (Director of Cardiovascular Surgery), Dr. Wolfgang Schiller (cardiothoracic surgeon), Dr. Christoph Hammerstingl (echocardiology) and Dr. Maurice Buchbinder (interventional cardiologist, Founder and Medical Director of MValve).  

"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," said Professor Grube.

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

The MValve transcatheter docking device in combination with the Lotus^TM  transcatheter heart valve were implanted successfully. Post-operative imaging confirmed the valve was positioned perfectly and functioning well with no residual regurgitation.  

"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^TM 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," said Dr. Buchbinder.

"I would like to take this opportunity to thank the incredibly talented physicians in Bonn and the MValve team who made this possible.  The potential of catheter based mitral valve replacement therapy has become increasingly evident. MValve's unique approach is a breakthrough that will undoubtedly enhance this most promising treatment modality," said Assif Stoffman, Chief Executive Officer and co-founder of MValve.  

MValve Ltd is a privately held company founded in 2011, with lead investment from Boston Scientific Corporation. MValve is dedicated to the development of novel and minimally invasive technologies for transcatheter valve replacement.  The company operates from Herzeliya, Israel and San Diego, USA.

SOURCE Mvalve Technologies LTD.