Sahajanand Medical Technologies receives regulatory approval in Canada

Sahajanand Medical Technologies Limited (SMT) has secured a Class IV medical device license from Health Canada’s Medical Devices Directorate for its Supraflex Cruz sirolimus-eluting coronary stent system. This regulatory approval marks the company’s entry into the North American market.

The license covers the Supraflex Sirolimus Eluting Stent System family, which includes the Supraflex Cruz. This authorization allows the device to be imported and sold within Canada, supporting SMT’s strategy to increase the international availability of its coronary-intervention technologies.

According to SMT Chief Commercial Officer Anil Suri, the approval is a meaningful step in expanding access to the platform. The expansion comes as heart disease remains a major public health issue in Canada; in 2023, heart disease was the country’s second-leading cause of death, claiming 57,890 lives.