NewsVoir
Mumbai (Maharashtra) [India], September 9: Sahajanand Medical Technologies Limited (SMT) has received a Class IV medical device license from Health Canada’s Medical Devices Directorate for its Supraflex Cruz sirolimus-eluting coronary stent system, marking the company’s entry into a new North American market.
The family license covers the Supraflex Sirolimus Eluting Stent System and lists Supraflex Cruz as a licensed device within that family. The license enables the device to be imported and sold in Canada and advances SMT’s strategy to expand the international availability of its coronary-intervention technologies.
[Heart disease remains a significant public health burden in Canada. In 2023, 6.3% of Canadians aged 18 and older reported having been diagnosed with heart disease or having experienced a heart attack. Heart disease also claimed 57,890 lives that year, making it the country’s second-leading cause of death. [1] Between April 2023 and March 2024, approximately 8.2% of Canadians aged over 20 were living with diagnosed ischemic heart disease and over 170,000 new cases are diagnosed every year. [2]
Commenting on the company’s expansion into Canada, Anil Suri, Chief Commercial Officer, at SMT said “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,”
The Supraflex Cruz approval builds on SMT’s expanding international presence and reflects the company’s commitment to making its coronary-intervention technologies available to physicians in markets where cardiovascular disease remains a major public health priority.
The Canadian license comes amid a growing body of clinical evidence for Supraflex Cruz. Findings presented at TCT 2025 included results from TUXEDO-2, which enrolled 1,800 patients with diabetes and multivessel coronary artery disease and demonstrated the non-inferiority of Supraflex Cruz versus a contemporary drug-eluting stent for target lesion failure at one year. Results from MULTIVESSEL TALENT, which randomized 1,550 patients with three-vessel coronary artery disease across 54 sites in Europe and the United Kingdom, demonstrated the non-inferiority of Supraflex Cruz versus a contemporary drug-eluting stent for the trial’s primary composite endpoint at 12 months.
About Supraflex Cruz
Supraflex Cruz DES belongs to the Supraflex family of stents, which, through a series of clinical trials including the TALENT trial and has demonstrated safety and effectiveness comparable to the drug-eluting stents evaluated in those trials.
About SMT (Sahajanand Medical Technologies)
SMT (Sahajanand Medical Technologies Limited) is a medical devices company with a portfolio of technologically advanced medical devices across vascular and structural heart intervention. SMT offers an extensive portfolio of products focusing on vascular intervention and was the first company in the world to receive CE certification for a DES with a biodegradable polymer. SMT has a global presence, exporting products to more than 75 countries, as on March 31, 2025.
For further updates, please the website or follow SMT on LinkedIn.
[1] Statistics Canada, “Heart disease and strokes: Two different afflictions, one common risk factor,” February 5, 2026.
[2] Public Health Agency of Canada, “Heart disease: For health professionals,” February 12, 2026.
Sahajanand Medical Technologies Limited is proposing, subject to receipt of requisite approvals, market conditions and other considerations, an initial public offer of its equity shares and has filed a draft red herring prospectus dated July 25, 2025 (“DRHP”) with the Securities and Exchange Board of India (“SEBI”) and the stock exchanges. The DRHP is available on our website at www.smtpl.com as well as on the website of SEBI at www.sebi.gov.in, Motilal Oswal Investment Advisors Limited at www.motilaloswalgroup.com, Avendus Capital Private Limited at www.avendus.com, HSBC Securities and Capital Markets (India) Private Limited at www.business.hsbc.co.in and Nuvama Wealth Management Limited at www.nuvama.com and and the websites of the stock exchange(s) at www.nseindia.com and www.bseindia.com, respectively. Any potential investor should note that investment in equity shares involves a high degree of risk and refer to the Red Herring Prospectus, including the section titled “Risk Factors” of the Red Herring Prospectus when available, for details. Potential investors should not rely on the DRHP for any investment decision.
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SMT's Supraflex Cruz Coronary Stent Receives Regulatory Approval in Canada
