25 June 2018 | News
The seven year study revealed a long-term safety of the biodegradable polymer coated Supralimus SES in patients
SMT (Sahajanand Medical Technologies Pvt. Ltd.), India’s largest manufacturer of cardiovascular medical stents, today, announced the successful clinical study result of their Biodegradable Polymer Coated Supralimus Sirolimus-Eluting Stent(S-SES) in India.
The result came from an observational and retrospective study that was carried out in 346 patients with a follow-up compliance of 94.5% (327 patients) in seven years. The aim of the study which started in January 2011 was to assess seven-year clinical outcomes of biodegradable polymer coated Supralimus Sirolimus-Eluting stent at Shree B.D. Mehta Mahavir Heart Institute, Surat.
The study was conducted by an independent clinical research organization and was supervised by an independent cardiologist from a remote institute.
Titled as ‘Seven-year clinical outcomes in patients undergoing percutaneous coronary intervention with biodegradable polymer coated sirolimus-eluting stent: Results from a single-center real-world experience’, was presented at EURO PCR 2018 in Paris and was published in Indian Heart Journal this year. The module for the study and population included all real-world patients who were implanted with the S-SES during the said period.
In this clinical study, patient population had high rates of hypertension (34.9%), hypercholesterolemia (31.2%), high complex (61.4%) lesions, and total occluded (4.7%) lesions. The seven year study revealed a long-term safety of the biodegradable polymer coated Supralimus SES in patients.
The principal investigator of the study Dr. Atul Abhyankar, Interventional Cardiologist, said, “The present study is the first ever longest study conducted on biodegradable polymer coated SES. Regardless of the complicated patient population for this study which is usually challenging, the study showed remarkable results. The interesting part of this study is that there is a high percentage of follow-ups of patients which has shown satisfactory and sustained seven –year clinical outcomes suggesting long-term benefits of biodegradable polymer-based SES.”
Mr. Ganesh Sabat, CEO, SMT said, “The result from this study answers a very critical question regarding safety and efficacy of our drug coating technology. The longest ever follow up data also signifies our commitment towards sustained effort on innovation and building a unique product. More importantly it gives scientific proof and strong clinical evidence to the cardiologist community to use our product with confidence. The patients implanted with SMT stents should be free of worries for the rest of their life.”