CE mark for Supraflex Cruz stent system

September 6, 2019 0 By FM

Sahajanand Medical Technologies (SMT) has announced that it has received CE Mark for its next-generation Supraflex stent system called Supraflex Cruz.

Supraflex Cruz is a sirolimus-eluting stent built on a cobalt chromium platform having implanted in more than 2,50,000 patients in India and in selected international markets over the last 3 years.

The stent design provides ultrathin strut thickness (60 microns for all diameters and lengths), a blend of proprietary biodegradable polymers to release the drug, very thin layer of polymers, high radial strength and low crossing profile.

Supraflex Cruz has undergone multiple clinical studies including the most advanced OCT studies (Sibi and Taxco OCT study) showing healing pattern post-deployment of the stent.

Sibi OCT study demonstrated that Supraflex Cruz had close to 91% endothelialisation in 35 days. In the Taxco study, the stent was compared with market leading Everolimus-eluting stent in a head to head comparison at 6 months. The study showed both the stents had more than 97% endothelialisation at 6 months.

Faster endothelization represents better healing pattern.

Further clinical studies on Cruz are planned across Europe, India, Latin America and the rest of the world in the coming 2 years. These clinical trials will test Supraflex Cruz in a challenging patient population in randomised clinical trials including multivessel, diabetics, ACS, high bleeding risk patients and Fragile patients (age over 75years).

The company recently completed Talent trial in Europe involving 23 centres in 7 countries on 1435 patients which were published in The Lancet.