India's First Indigenous Drug Eluting Stent Receives CE Approval

Sahajanand Medical Technologies (SMT) has received CE approval (Conformité Européenne), an authorisation certificate, for qualification for the sale of Infinnium in European community and many other countries in the world. The Infinnium paclitaxel eluting coronary stent system is the first (Asian) indigenously developed coronary stent for the treatment of coronary artery disease (CAD) and offers unmatched clinical outcomes with excellent safety profile.

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, informs a company release.

"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.

Besides SMT, there are only 4 more companies in the world to have got the CE authorisation for their DES out of 40 companies worldwide.

(Ref : Chronicle Pharmabiz dated December 15, 2005)