NewsVoir
Mumbai (Maharashtra) [India], October 29: Sahajanand Medical Technologies (SMT) announced significant new findings from four landmark clinical studies, namely TUXEDO II, Multivessel TALENT, Cruz Senior Study, and the SFlex Netherlands Registry, presented at the TCT 2025 conference. The collective data reinforces the proven safety, efficacy, and consistent performance of the Supraflex Cruz drug eluting stent (DES) across a broad spectrum of complex patient populations.
In the TUXEDO-II Trial, which compared Supraflex Cruz with Xience in diabetic patients with multivessel disease, 1,800 patients were enrolled across 66 sites in India under the leadership of Chairperson Dr. Upendra Kaul (India) and Co-chair Dr. Sripal Bangalore (USA). The primary endpoint was Target Lesion Failure (TLF) at one year. Supraflex Cruz demonstrated comparable clinical outcomes to Xience, with a numerically lower rate of target lesion revascularization (TLR) (log-rank p = 0.44). TLF rates were also comparable between the two groups (HR = 0.89, 95% CI: 0.64-1.23, p = 0.49), supporting the non-inferiority of Supraflex Cruz in this high-risk diabetic population.
Dr. Upendra Kaul, Study Chair of the TUXEDO-II trial, said, "The findings from TUXEDO-II reaffirm that Supraflex Cruz performs well in diabetic patients with multivessel disease, one of the most challenging and high-risk subsets in interventional cardiology. The trial validates the safety and clinical reliability of biodegradable polymer technology in this demanding population."
Dr. Sripal Bangalore, Co-Chair of the TUXEDO-II trial, added, "TUXEDO-II results demonstrate that the Supraflex Cruz stent achieves clinical outcomes at par with leading durable-polymer stents, offering interventionalists a strong and proven alternative for diabetic multivessel revascularization."
The Multivessel TALENT Trial, chaired by Prof. Patrick W. Serruys (Ireland) and conducted by CORRIB laboratories across 54 sites in Europe with 1,550 patients, compared Supraflex Cruz with Synergy in three-vessel coronary artery disease. The primary endpoint was the Patient-Oriented Composite Endpoint (POCE) at 12 months. Supraflex Cruz was found to be non-inferior to Synergy, with a numerically lower POCE rate when excluding periprocedural myocardial infarction (MI). POCE with periprocedural MI was 15.3% for Supraflex Cruz versus 14.6% for Synergy (log-rank p = 0.668), while POCE without periprocedural MI (NOBLE-1 definition) was 9.7% versus 9.2% (log-rank p = 0.799). In the subset of patients with SYNTAX score >33, POCE for Supraflex Cruz was numerically lower than Synergy, 14.6% vs 22.8%, log rank p=0. 167.These findings underscore the strong performance of Supraflex Cruz in complex three-vessel disease.
Prof. Patrick W. Serruys, Chair and Chief Investigator of the Multivessel TALENT trial, remarked, "The Multivessel TALENT study establishes the non-inferiority of Supraflex Cruz compared to Synergy, confirming its robust clinical performance in patients with three-vessel disease. This trial extends the scope of use Supraflex Cruz into a population representing the frontier of complex PCI (Percutaneous Coronary Intervention)."
The Cruz Senior Study has demonstrated that PCI (Percutaneous Coronary Intervention) using the SMT Supraflex Cruz stent platform is both safe and effective in patients aged 80 years and older. Including octogenarian and nonagenarian patients, the study strives to represent a breakthrough in understanding coronary intervention outcomes in one of the most vulnerable and often underrepresented populations. Cruz Senior assessed not only clinical endpoints but also patient-reported outcomes (PROMs) and frailty markers, offering a comprehensive view of real-world impact. Results revealed promising procedural success rates and a strong safety profile, with patients experiencing a meaningful reduction in symptoms and improvement in quality-of-life following treatment.
"These results are a testament to how far modern stent technology has evolved," said Prof. Dr. David Leistner, Principal investigator, Cruz Senior Study from the University Heart Center Frankfurt/Main. "For the first time we're seeing evidence that even our most elderly patients can benefit safely and significantly from PCI when performed with the SMT Supraflex Cruz platform.The findings underscore the potential of the SMT Supraflex Cruz stent to extend the benefits of PCI to a wider range of patients, reinforcing its role as a trusted solution in advanced interventional cardiology."
The SFlex Netherlands Registry, led by Dr. A.J.J. Ijsselmuiden, evaluated real-world outcomes in 5,000 patients across 10 sites in the Netherlands, focusing on TLF at one year as the primary endpoint. Supraflex Cruz demonstrated low rates of clinically driven TLR (2.1%) and stent thrombosis (0.8%) at one year, affirming its consistent safety and efficacy in everyday clinical use.
Dr. Ijsselmuiden Principal Investigator, SFlex Netherlands Registry cited, "The large-scale SFlex Netherlands registry provides compelling real-world data from thousands of patients, reinforcing the consistency, safety, and reliability of the Supraflex platform across routine clinical practice."
Dr. Krishna, Chief Medical Officer at Sahajanand Medical Technologies, commented, "The consistent and robust outcomes observed across these pivotal trials reaffirm our commitment to advancing interventional cardiology through innovation and evidence-based medicine. Supraflex Cruz continues to demonstrate reliability across diverse and complex patient populations, validating the strength of SMT's research-driven approach and our focus on improving patient outcomes worldwide."
Together, the pivotal TUXEDO II, Multivessel TALENT, Cruz Senior Study, and SFlex Netherlands studies position Supraflex Cruz as a next generation drug eluting stent that delivers consistent and robust outcomes across high risk, multivessel, and real-world patient populations, reaffirming SMT's unwavering commitment to advancing interventional cardiology worldwide.
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.
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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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