Sahajanand Medical Technologies Pvt. Ltd. (SMT), India’s largest manufacturer of cardiovascular medical stents, has set a new benchmark in the Indian industry with the commencement of Talent Randomized Clinical Trial (RCT) for their Supraflex Stents product line. This study will be conducted across 7 countries i.e. United Kingdom, Netherlands, Poland, Spain, Italy, Hungary and Bulgaria in 26 centres with a sample set of 1430 patients.
SMT with the latest RCT trial are set to compete with global players. RCT is considered to provide highest level of evidence about the quality of the product in the clinical trial world. Medical fraternity views RCT as the highest level of evidence for assessing the quality of a medical product. It ensures that all the bias is eliminated and there is a fair comparison of how two products would function in a patient.
Speaking on the occasion, Ganesh Sabat, CEO, SMT said “We take immense pride to be the first Indian company to have commenced randomized clinical trial in Europe. We are absolutely thrilled and confident from our experience of last 15 years that our product will match the safety and efficacy of the best of the technology available in the market. This study will also put Indian medical device industry on the world map and has the potential to make India as a hub for medical device. The biggest challenge faced by medical device player from India is perception factor due to our origin and we believe we can prove beyond doubt about the high quality of our product. We are thrilled and looking forward to the results. This study will enable SMT to aggressively pursue large market share in interventional cardiology market in Europe.”
Talent RCT is a clinical trial in which there are minimum two treatment arms. The patient once enrolled will be randomized to either of the treatment arms. The randomization is pre-decided by an external agency, ECRI. The reason to have this randomisation is to remove the bias that the patient or doctor may have towards any particular treatment. The study will be chaired by Prof Patrick Serruys, who is a prominent opinion leader in the world. He has been at the helm of the biggest and the most important landmark trials which have shaped the current practises in interventional cardiology.
Commenting on the occasion, Bhargav Kotadia, vice chairman, SMT said, “Our core value has been bettering the healthcare infrastructure in India and making it affordable and accessible to all. In a move to enlighten our key stakeholders across customers, medical fraternity, and policy makers, we decided to commission this study. The study will compare our product Supralex Stent against globally accepted product from MNC. This trial will set a benchmark and change the perception of people about the Indian stents. By comparing Supraflex with the world standard product will help us prove non inferiority and will get us into next orbit of growth. It will further help Indian stent manufacturers get equal importance and recognition in the industry.”
This RCT is a non-inferiority trial to compare Supraflex Stent (SMT’s ultra thin 60 micron Sirolimus Eluting stent with biodegradable polymer Vs Xience Family which is the world standard product of Abbott) in the ratio of 1:1. This trial is essentially to prove that Supraflex Stent which is currently approved for sale in Europe is non-inferior to Xience which is the world standard.