MitrAssist Medical has obtained ISO 13485:2003 certification for the design of implantable mitral valve prostheses.
By using a minimally invasive procedure, the mitral valve prosthesis is delivered via a small-diameter catheter, thus keeping the existing valve intact.
The design of mitral valve prosthesis helps to preserve the ventricular dynamic mode function and mechanism, known to be crucial for long term patient outcome.
MitrAssist founder and CEO Gil Naor said, "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."
Source:
http://certification.medicaldevices-business-review.com/news/mitrassist-wins-iso-certification-for-design-of-mitral-valve-prostheses-050612
