Mumbai / London: SMT (Sahajanand Medical Technologies Pvt. Ltd.), India’s largest manufacturer of cardiovascular medical stents, announced the successful results of S flex UK Registry. The one-year outcome data of the study was presented at The British Cardiovascular Intervention Society (BCIS), 2018 held at London, UK.
The outcome clearly demonstrated the safety and clinical performance of Supraflex, Sirolimus-Eluting Coronary Stent System thereby setting a new benchmark in Indian cardiovascular industry, which is ready to compete with global players.
Titled as Prospective Evaluation of the Supraflex, Sirolimus-Eluting Coronary Stent System in a ‘Real-World’ Patient Population, the S Flex UK Registry trial was conducted among 469 patients from July 2015 to November 2016. The study was conducted at 11 hospitals in the UK. The Primary endpoints of the study were Target Lesion Failure (TLF) at 12 months (Cardiac death, target vessel MI, or clinically-driven TLR).
This real world, all comers, multi-center UK registry of 469 patients undergoing PCI showed that the Supraflex stent to be safe with a TLF rate of 3.2% with no definite stent thrombosis, potential plus probable stent thrombosis incidence of 0.9% at 360 days.
The principal investigator of the study Dr. Azfar Zaman, Professor of Cardiology, Freeman Hospital and Newcastle University, UK said, “The One-year safety and efficacy outcomes clearly highlight the excellent safety profile and excellent deliverability of Supraflex which is essential for PCI procedures. We believe ultrathin 60-micron struts, biodegradable polymer, and proven antiproliferative drug are the intrinsic elements of the superior performance of Supraflex.”
“We are pleased to be able to report these excellent one-year results, confirming that Supraflex can be considered the new benchmark for DES, beginning of a new era of Ultrathin stents. We are committed to nurturing the meaningful innovations that deliver better patient outcomes. Here we leverage a decade-long healing experience while bringing the best of efficacy and safety outcomes offered through SMT DES.” added Mr. Cheran Uthirapathi, VP International Sales & Marketing, SMT.
Ecstatic about the successful results of S flex UK Registry Mr. Piyush Savalia, Sr. V.P. Marketing & Clinical Trial, SMT said, “Evidence-Based Medicine is at the core of SMT’s product development strategy. Given the consistency with which the Supraflex stent has performed across the wide spectrum of clinical parameters through various other clinical studies, we are upbeat that UK S Flex study has produced positive and excellent clinical outcomes that physicians expect from a next-generation DES”
About Supraflex (Designed for Distal Delivery)
The CE-approved Supraflex, new biodegradable polymer-coated sirolimus-eluting stent (SES) is designed using an ultrathin (60μm) cobalt–chromium (Co–Cr) stent platform with a highly flexible ‘S-link’, which would enhance the deliverability of the stent, particularly in complex and challenging lesions. Clinical trial programme on Supra family of products has covered more than 12000 patients across the world till date.