Contract manufacturing TMVR

A startup medical device company engaged us in developing a Transcatheter Mitral Valve (TMVR) based on their IP. Company was developing a novel percutaneous mitral valve replacement system. This was an end to end project, where clients relied on our expertise to produce the TMVR valve from the scratch. Our client lacked the in-house resources like clean rooms, wet and dry labs, testing equipment and other resources. Also it lacked the required high skilled human resources talent.

We were involved with the project from the beginning starting procuring the bovine tissue from slaughter house to fixing the tissue. Once the tissue was fixed we’re involved in sewing the tissue on to the stent to produce the valve. We worked very closely with the client team in tweaking the stent and delivery system design several time to come with the workable stent and the valve. We successfully produced the TMVR valve for animal and FIH clinical trials. Also our team consulted the company regarding various testing, regulatory and compliance related aspect.