By: IPP Bureau
Last updated : September 09, 2026 6:29 pm
The approval gives SMT access to another regulated North American market as the company continues to build its international coronary intervention business
Sahajanand Medical Technologies Limited (SMT) has received a Class IV medical device licence from Health Canada’s Medical Devices Directorate for its Supraflex Cruz sirolimus-eluting coronary stent system, marking the company’s entry into the Canadian market.
The family licence covers the Supraflex Sirolimus Eluting Stent System, with Supraflex Cruz listed as a licensed device within the product family. The approval allows SMT to import and sell the device in Canada and supports the company’s strategy to expand the international reach of its coronary intervention portfolio.
“Canada is an important market for SMT, and this approval represents a meaningful step in expanding access to Supraflex Cruz. We are committed to supporting physicians with a clinically supported coronary-stent platform as they care for people living with coronary artery disease,” said Anil Suri, Chief Commercial Officer, SMT.
The Canadian approval comes as cardiovascular disease continues to represent a significant health burden in the country. According to the data cited by SMT, 6.3% of Canadians aged 18 and above reported being diagnosed with heart disease or having experienced a heart attack in 2023. Heart disease accounted for 57,890 deaths that year, making it the country’s second-leading cause of death.
Between April 2023 and March 2024, approximately 8.2% of Canadians aged over 20 were living with diagnosed ischemic heart disease, with more than 170,000 new cases reported annually.
SMT said the Canadian licence adds to its expanding international presence and strengthens its efforts to make its coronary intervention technologies available across markets with a significant cardiovascular disease burden.
The approval also comes against the backdrop of growing clinical evidence supporting Supraflex Cruz. Data presented at TCT 2025 from the TUXEDO-2 trial, which enrolled 1,800 patients with diabetes and multivessel coronary artery disease, showed that Supraflex Cruz was non-inferior to a contemporary drug-eluting stent for target lesion failure at one year.
Results from the MULTIVESSEL TALENT trial, involving 1,550 patients with three-vessel coronary artery disease across 54 sites in Europe and the UK, also demonstrated non-inferiority of Supraflex Cruz compared with a contemporary drug-eluting stent for the study’s primary composite endpoint at 12 months.
The Health Canada approval expands the commercial footprint of Supraflex Cruz and gives SMT access to another regulated North American market as the company continues to build its international coronary intervention business.