MitrAssist Medical’s ISO Certification

ISO 13485:2003 Certification is the next step toward the development of the company’s implantable heart valve prostheses.

Gil Naor, founder and CEO, MitrAssist Medical Ltd., a company that is the developer of minimally invasive products for treating heart disease, announces that the company has 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," Naor states