Boston Scientific Investment Will Fund MValve's FIH Trial

October 8, 2015—Boston Scientific Corporation announced that it has closed on an additional round of financing with MValve Technologies Ltd., an Israel-based developer of a percutaneous mitral valve replacement system, designed to work with the Boston Scientific Lotus transcatheter mitral valve, to treat mitral regurgitation. Boston Scientific has provided the company with funding since 2012 and has an exclusive option to acquire MValve.

MValve Technologies plans to use the new financing, in part, to fund a first-in-human clinical trial for the MValve docking system for transcatheter mitral valve replacement in patients with mitral regurgitation. 

On October 5, MValve announced the successful first-in-human implantation of the 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.

In the procedure, the Lotus valve is deployed inside the MValve docking system. This approach is designed to enable the treatment of mitral regurgitation in a broad range of patients, and to improve long-term clinical outcomes in this patient population. Both the dock and valve can be repositioned and recaptured, enabling precise valve placement.

The MValve docking system is not available for sale. The Lotus valve system has received European CE Mark approval. In the United States, the Lotus valve is an investigational device and not available for sale, advised Boston Scientific.