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. 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 interventional cardiology field," said Manish Doshi, CEO, SMT.
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. The CE approval will enable SMT to open up new markets and territories. This company will now be able to market this stent across Maharashtra and other states.
Infinnium paclitaxel eluting coronary stent is a small serpentine mesh of slotted tubes coated with drug (paclitaxel) and biodegradable polymers, used to open blocked coronary arteries during angioplasty procedures. They have been confirmed to be superior options to traditional treatments (bare metal stent and balloon angioplasty) and are known to significantly reduce the rate of repeat procedures due to re-blockage of coronary arteries (restenosis) in patients with CAD, added the release.
SMT is the largest producers of coronary drug eluting stents outside of North America. SMT is an ISO 9001:2000 and ISO 13485:2003 certified company and its facilities are GMP certified. The company has its manufacturing facilities located in Daman, Gujarat.