Positive 3-Year Results from FIRE Trial Demonstrate Supraflex Cruz's Safety and Efficacy in Elderly Heart Attack Patients

NewsVoir

Mumbai (Maharashtra) [India], September 15: Sahajanand Medical Technologies (SMT), a medical devices company with a portfolio of technologically advanced medical devices across vascular and structural heart intervention, announced positive 3-year results from the FIRE Trial, presented at ESC 2025, reaffirming the safety and efficacy of its Supraflex Cruz drug-eluting stent in patients aged 75 years and older with myocardial infarction (MI) and multivessel disease.

The FIRE Trial is a study evaluating revascularization strategies in elderly MI patients with multivessel disease. 1,445 patients across 34 centres in Italy, Spain, and Poland were randomized to functionally guided complete revascularization or culprit-only treatment, with Supraflex Cruz as the stent of choice. The primary endpoint was the patient-oriented composite of all-cause death, MI, stroke, and revascularization, assessed over three years.

At a 3-year follow-up, among older patients with MI and multivessel disease, physiology-guided complete revascularization, as compared to a culprit-only revascularization strategy, reduced risk of primary and key secondary endpoints. As per the data presented at ESC Congress, results also showed consistently low stent thrombosis rates (1.03% at 1 year; 1.17% at 3 years) and a lowered risk of adverse cardiovascular events, reinforcing the benefits of physiology-guided complete revascularization in high-risk patients.

Prof. Gianluca Campo, Study Chair, stated, "The FIRE trial demonstrates that physiology-guided complete revascularization using Supraflex Cruz lowered the risk of a composite endpoint of death, MI, stroke, or ischemia-driven revascularization compared to a culprit-only approach. Importantly, these benefits were sustained over 3 years, with a very low rate of stent thrombosis at both 1 and 3 years, highlighting the safety and reliability of Supraflex Cruz in elderly patients with multivessel disease."

Dr. Simone Biscaglia, Principal Investigator, added, "The FIRE trial shows that physiology-guided complete revascularization with Supraflex Cruz offers benefits in elderly MI patients with multivessel disease. It reduced primary endpoints versus a culprit-only approach, with sustained benefits over three years and very low stent thrombosis rates, confirming the safety and efficacy of Supraflex Cruz."

Dr. Krishna Sudhir, Chief Medical Officer, SMT, commented, "The FIRE Trial reinforces evidence from TALENT, COMPARE 60/80, and other studies showing Supraflex Cruz consistently delivers positive outcomes in high-risk patients. With safety and enhanced deliverability, Supraflex Cruz continues to set benchmarks in coronary care globally."

SMT (Sahajanand Medical Technologies) 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 with its footprints in more than 75 countries, as on March 31, 2025.

For further updates, please the website or follow SMT on LinkedIn.

Supraflex Cruz DES belongs to the Supraflex family of stents, which, through a series of clinical trials including the TALENT trial, have been proven to be clinically safe and effective as compared to other DES in clinical practice.

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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