SMT to conduct quality trials of its stents in Europe

NEW DELHI: Indian stent maker Sahajanand Medical Technologies (SMT) has begun clinical trials across seven European countries to prove the quality of its ‘Supraflex’ matches global stent giant Abbott’s Xience.
SMT claims it is the first Indian medical devices company to initiate a randomized clinical trial (RCT) to prove non-inferiority of its product—a decision it says it took because patients are sceptical about medical devices made here.

The company will test the quality, safety and efficacy of 86 variations of Supraflex stents against their Xience equivalents between now and 2018. Supraflex is a drug-eluting stent with a biodegradable polymer, meaning the coating that regulates the delivery of the drug from the stent into the arterial tissue will disappear over time.

The trials will be conducted in 1,430 patients across UK, Netherlands, Poland, Spain, Italy, Hungary and Bulgaria. Half the patients will be administered Supraflex stents while the others will use Xience stents, according to SMT.

So far, 75 patients have enrolled for the trials, which will be overseen by Imperial College London cardiology professor Patrick Serruys and Upendra Kaul, a pioneer of interventional cardiology in India. SMT has invested close to 10 million euros for this study, company CEO Ganesh Sabat told ET.

“This study will show that Indian products are of high quality,” said Sabat. “We have the scale and size right now to challenge the best in the world.”

SMT has already conducted studies with Supraflex on over 4,000 patients since its launch in India in 2012, he added.

Supraflex is priced competitively in the country and would be a more affordable alternative to other imported stents, according to Sabat. The company produces 20,000 Supraflex stents a month and at least half cater to Indian patients, he added.

The brand constitutes nearly 80% of SMT’s revenue, which crossed Rs100 crore last year, he said.