A global study has found a Made-in-India stent, Supraflex, clinically at par with Abbott’s Xience.
Supraflex is manufactured by Surat-based Sahajanand Medical Technologies (SMT). It is available in 65 countries. It has advanced features like biodegradable polymer and ultrathin strut thickness and biostable polymer coating of Xience, said Ganesh Sabat, CEO, SMT, in a statement here on Monday.
Over 500,000 stents are used in India every year. A cardiac stent is a device used to unblock clogged arteries. Drug eluting stents are coated with medicines that help lower recurrence chances of an artery narrowing after corrective surgery.
Dr Patrick Serruys, a globally-renowned cardiology researcher, said the safety and efficacy of Supraflex SES with ultra-thin struts and biodegradable polymer, was found to be “non-inferior to the Xience for DOCE (device-oriented end points).”
He was the chair for the clinical trial findings presented at a global conference of cardiologist, currently underway in San Diego, USA. This study was conducted in the United Kingdom, Netherlands, Poland, Spain, Italy, Hungary and Bulgaria across 23 centres with a sample size of 1,435 patients. Xience is regarded as global standard in safety and efficacy for drug eluting stents.
Well-known Indian cardiologist, Dr Upendra Kaul, who was decorated with a Padma Shri, was the co-chair of the study. “There remained a perception that stents produced outside of India were superior to homegrown devices. There were demands from Indian manufacturers to prove that their devices are comparable to those made elsewhere in robust clinical trials.”
The trial included mean patient age of 65 years, and about three-quarters were men, with about 40% of patients presenting with stable angina and 60% with Acute Coronary Syndromes (ACS).
In a per protocol analysis, Supraflex had better efficacy as compared to Xience.
The clinical trial, known as TALENT ( T hin strut sirolimus-eluting stent in al l-comers population vs everolimus eluting ste nt ), was carried out 1:1 comparing ultra-thin drug eluting stent Supraflex with Xience family of stents from Abbott.
SMT, a pioneer in bio-degradable polymer and ultra-thin struts technology, is the first indigenous player in India to successfully launch coronary stent. It has a strong international presence with global footprint. It is India's largest stent manufacturing company and second in terms of market share in India.