The Talent RCT will test the quality, safety and efficacy of 86 variations of Supraflex stents against their Xience stents with 715 patients each
Sahajanand Medical Technologies (SMT), becomes the first Indian medical device manufacturing company to commence a Talent Randomised Clinical Trial (RCT) for their Supraflex stent product line with a sample set of 1430 patients.
“This study, chaired by Prof Patrick Serruys, is conducted across the UK, Netherlands, Poland, Spain, Italy, Hungary and Bulgaria in 26 centres. The Talent RCT is a clinical trial which provides the highest level of evidence about the medical quality of the product . In this trial we are seeing the scientific equivalence between Supraflex stent with Xience stents and how are the two already approved products would function in a patient,” said Prof Upendra Kaul, Executive Director and Dean (academics) at Fortis-Escorts Heart Research Institute.
The Talent RCT will test the quality, safety and efficacy of 86 variations of Supraflex stents against their Xience stents with 715 patients each and the final result of the Talent RCT will be given in 2018.
The trial has minimum two treatment arms and the patient once enrolled will be randomised to either of the treatment arms. The reason to have this randomisation is to remove the bias that the patient or doctor may have towards any particular treatment.
Speaking on the occasion, Ganesh Sabat, CEO, SMT said “ Supraflex stent costs start from Rs 23,600 to an upper limit of Rs 1,40,000. This study will enable SMT to aggressively pursue large market share in interventional cardiology market in Europe.”
Supraflex it is a drug-eluting stent with a biodegradable polymer, the coating that regulates the delivery of the drug from the stent into the arterial tissue will disappear within six to eight months.