Sahajanand's Infinnium Receives CE Approval

EHM News Bureau - Mumbai

Sahajanand Medical Technologies (SMT) has recently received CE Approval (Conformité Européenne) – an authorisation certificate for qualification for sale in European community and many other countries in the world. The CE approval of Infinnium was based on stringent review of chemical pharmaceutical data, pre-clinical data and clinical (human trials) data demonstrating sustained long term efficacy and excellent safety. “SMT is proud to be the only Indian company to have received CE Mark for our indigenously developed Infinnium Paclitaxel Eluting Coronary Stent which will help make the DES therapy affordable for millions of patients suffering from CAD. Currently, Infinnium is approved and marketed in 28 countries. Post CE approval, SMT aims to target 140 countries. Apart from the ongoing research, SMT has more projects in its R&D portfolio including nano particles, bio-degradable stents and other devices related to the field of interventional cardiology,” said Manish Doshi, CEO, SMT.

The CE Approval will enable SMT to open up new markets and territories. The excellent safety and efficacy outcome of CE approved Infinnium Paclitaxel eluting stent is proven in SIMPLE trials.