Sahajanand Medical Technologies Pvt. Ltd. (SMT), which is India’s largest manufacturer of cardiovascular medical stents, has become the first Indian medical devices manufacturing company to commense the Talent Randomised Clinical Trial (RCT) for their Supraflex stents product line.
The study, to be chaired by world’s leading cadiologist Prof Patrick Serruys, will be conducted in 26 centres across seven countries — the UK, Netherlands, Poland, Spain, Italy, Hungary and Bulgaria — with a sample set of 1,430 patients. It will help SMT compete with global players.
“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,” said Ganesh Sabat, CEO, SMT, while speaking on the occasion.
Medical fraternity considers RCT as the highest level of evidence about the quality of a product. It ensures that all the bias is eliminated and there is a fair comparison of how two products would function in a patient.
“We take immense pride to be the first Indian company to have commenced Randomised 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,” Sabat said.
Talent RCT is a clinical trial in which there are minimum two treatment arms. The patient once enrolled will be randomised to either of the treatment arms. The randomisation 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.
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,” he added.