Sahajanand Medical Technologies (SMT), a leading global medical device company, announced that it has received a Class IV medical device licence from Health Canada for its flagship Supraflex Cruz™ sirolimus-eluting coronary stent system. The regulatory milestone marks SMT’s official commercial entry into the Canadian interventional cardiology market.
The Class IV licence the highest risk classification under Canadian medical device regulations authorizes the import, distribution, and commercial sale of the Supraflex Cruz™ system across Canada. Designed for high deliverability and procedural success in complex coronary interventions, the drug-eluting stent features an ultra-thin strut profile combined with a biodegradable polymer coating engineered for controlled sirolimus release and rapid endothelial healing.
With cardiovascular diseases remaining a primary contributor to chronic morbidity and mortality nationwide, this approval broadens the therapeutic toolkit available to Canadian interventional cardiologists, offering a clinically proven, cost-effective technology to improve patient outcomes in coronary artery disease.
The Canadian market entry represents a key step in SMT’s North American expansion strategy, reinforcing its commitment to democratizing access to high-precision, clinically validated coronary interventional solutions across mature global healthcare systems.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
