BusinessWire India
Mumbai (Maharashtra) [India], September 24: Sahajanand Medical Technologies Limited (SMT), a leading global manufacturer of cardiovascular medical devices, today announced that it has received certification under the European Union Medical Device Regulation (EU MDR 2017/745) for Supraflex Cruz and its product family. SMT is a leading player in India’s drug-eluting stent market and ranks among the top five companies in key European markets, including Germany, Spain and Poland.
The certification follows the conformity assessment process established under EU MDR 2017/745 including assessment of SMT’s technical documentation, clinical evaluation and quality management system. Together with SMT’s existing ISO 13485 quality management system and MDSAP certifications, the EU MDR certification confirms that Supraflex Cruz has successfully undergone assessment against the EU MDR’s stringent requirements for safety, performance and clinical evidence.
Supraflex Cruz is a sirolimus-eluting coronary stent system designed to improve luminal diameter in occluded or stenosed coronary vessels, including de novo lesions and restenosed vessels. The product has supported the treatment of more than 2.5 million patients in over 75 countries. Its clinical evidence base includes four randomized controlled trials involving more than 5,000 patients and seven real-world registries involving more than 13,000 patients, with findings published in leading peer-reviewed journals including The New England Journal of Medicine, JAMA, JACC, Circulation: Cardiovascular Interventions and BMJ Open.
“This certification is more than a regulatory milestone, it is a statement of who we are as a company,” said Bhargav Kotadia, CEO, SMT. “It reflects the technical rigour, clinical evidence and quality discipline our teams bring to everything we build. For physicians and patients across Europe and around the world who place their trust in Supraflex Cruz, it reinforces our commitment to uninterrupted access and dependable support. It is another step in SMT’s journey toward becoming a truly global leader in cardiovascular care.”
This milestone supports continuity of supply and patient access across Europe and globally.
“EU MDR significantly raised expectations for clinical evidence, technical documentation and post-market surveillance,” said Abhijeet Singhvi, CTO, SMT. “Achieving this certification reflects a strong cross-functional effort across our R&D, clinical, quality and regulatory teams. More broadly, it aims to reinforce the technology, clinical evidence and engineering discipline that underpin our next phase of innovation and growth in Europe and globally.”
Disclaimer: 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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