Coronary stent systems leading manufacturer gets CE marking

Published: Jul 15, 2019, 16:48 IST | Rupsa Chakraborty

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 last 3 years

Coronary stent systems leading manufacturer gets CE marking

A leading manufacturer of Coronary stent systems, SMT (Sahajanand Medical Technologies) on July 11 announced that it has received CE* Mark for its highly deliverable 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 last 3 years. The stent design provides physicians access to the most difficult and tortuous lesions with ease. The stent retains all the benefits of the Supraflex stent, viz, Ultrathin strut thickness (60 microns for all diameters and lengths), blend of proprietary biodegradable polymers to release the drug, very thin layer of polymers, high radial strength, and low crossing profile.

Cruz promises superior deliverability with an innovative design of dual Z link connecting valley to valley and better side branch access. With the help of Cruz, complex cases can be finished faster and harmful exposure of radiation to the physician will be reduced. Also, the trackability will void the need for additional hardware.

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. Faster endothelization represents better healing pattern.

Sibi OCT study demonstrated that Supraflex Cruz had close to 91% endothelialisation in 35 days. In the Taxco study, Supraflex Cruz 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.

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).

Talking about the latest announcement the CEO of SMT, Ganesh Sabat said, “We look forward to working with physicians across Europe to offer this highly deliverable drug-eluting stent to the thousands of patients who would have been unable to undergo PCI due to complex anatomy. “

The company recently completed Talent trial in Europe involving 23 centres in 7 countries on 1435 patients which were published in the most renowned medical journal ‘The Lancet’. In this trial, SMT’s Supraflex came out with flying colours against the market leader stent, showcasing best in class safety and efficacy in global patients’ population. Also, this trial was presented at a US Cardiology conference TCT MD in the late-breaking session.

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