MitrAssist receives ISO certification for design and development of mitral valve prosthesis

MitrAssist Medical Ltd., a developer of minimally invasive products for treating heart disease, announced today that it received ISO 13485:2003 Certification for the design and development of implantable heart valve prostheses.

Today's standard treatment for mitral valve regurgitation (MR), blood leakage or backflow into the atrium, is open heart surgery. MitrAssist's unique design preserves the ventricular dynamic mode of function and mechanism, known to be crucial for long term patient outcome. MitrAssist's mitral valve prosthesis is delivered with a minimally invasive procedure via a small-diameter catheter, keeping the existing valve intact. With its unique design focused on natural mitral valve anatomy, the MitrAssist mitral valve prosthesis will enable faster transition to minimally invasive procedures for mitral repair.

"This is yet another small step for us moving forward towards developing a viable and effective solution to Mitral Valve Insufficiency, following our successful completion of the chronic animal study POC," said Gil Naor, MitrAssist founder and CEO.