Sahajanand Medical Technologies Secures EU MDR Certification for Supraflex Cruz Coronary Stent Family
EU MDR Certification Strengthens SMT’s Position in the Global Cardiovascular Medical Device Market
Sahajanand Medical Technologies Limited (SMT), a leading global manufacturer of cardiovascular medical devices, has announced that its Supraflex Cruz coronary stent system and related product family have received certification under the European Union Medical Device Regulation (EU MDR 2017/745). The certification marks an important regulatory milestone for the company, supporting continued access to its coronary stent technology in European markets and reinforcing its commitment to product quality, clinical evidence, and patient safety.
SMT is a major supplier of drug-eluting stents (DES) in India and ranks among the top five companies in this segment in key European markets, including Germany, Spain, and Poland. The latest certification strengthens the company’s regulatory position in Europe and supports its broader strategy to expand its international presence in cardiovascular care.
The EU MDR certification was granted following a conformity assessment process conducted in accordance with the requirements of EU MDR 2017/745. The assessment included a comprehensive examination of SMT’s technical documentation, clinical evaluation, and quality management system. These evaluations are designed to establish whether medical devices meet the applicable regulatory standards for safety, performance, and clinical evidence.
Alongside SMT’s existing ISO 13485 certification for its quality management system and its Medical Device Single Audit Program (MDSAP) certification, the EU MDR approval provides further confirmation that Supraflex Cruz has undergone the required regulatory assessment. The certification reflects the company’s efforts to maintain established quality management practices and meet the regulatory expectations governing medical devices in the European Union.
Supraflex Cruz Supports Treatment of Coronary Artery Disease
Supraflex Cruz is a sirolimus-eluting coronary stent system designed to increase the lumen diameter in coronary arteries that have become narrowed or obstructed. The device is used in the treatment of coronary artery disease, including de novo lesions, which are newly identified arterial blockages, and restenosed vessels, where a previously treated artery has narrowed again.
The stent system delivers sirolimus, a medication intended to help reduce the risk of excessive tissue growth within the treated artery. Drug-eluting stents are used in coronary interventions to help maintain vessel openness following the procedure.
According to SMT, Supraflex Cruz and its related technology have been used to treat more than 2.5 million patients across over 75 countries. This international experience represents a significant part of the product family’s clinical and commercial history and reflects its use in a range of healthcare settings.
The product’s clinical evidence includes findings from four randomized controlled trials involving more than 5,000 participants. In addition, seven real-world clinical registries have collected data from more than 13,000 patients.
The results of these studies and registries have been published in several established peer-reviewed medical journals, including The New England Journal of Medicine, JAMA, Journal of the American College of Cardiology (JACC), Circulation: Cardiovascular Interventions, and BMJ Open.
These publications contribute to the clinical evidence supporting the product and provide information about its use in controlled clinical investigations and routine medical practice. The company’s regulatory certification process also involved a review of clinical evaluation documentation as part of the assessment required under the EU MDR framework.
Certification Supports European Market Access and Supply Continuity
The EU MDR certification is expected to help SMT maintain continuity of supply and access to Supraflex Cruz for patients and healthcare providers in Europe. Regulatory compliance is a central requirement for medical device manufacturers seeking to market products in the European Union, particularly as the EU MDR establishes detailed requirements for clinical evidence, technical documentation, quality management, and post-market surveillance.
For SMT, the certification represents an additional step in maintaining its presence in European markets while supporting the availability of its cardiovascular devices internationally.
The company operates in a medical technology sector where manufacturers must demonstrate that their products meet applicable safety and performance requirements throughout their lifecycle. Regulatory assessments also require companies to maintain documentation and systems that support the ongoing monitoring of medical devices after they enter the market.
By securing the certification for Supraflex Cruz and its related product family, SMT has completed a key regulatory milestone for its coronary stent portfolio under the European framework.
The development is also relevant to the company’s broader international operations, as SMT serves healthcare markets across multiple regions. The company stated that the certification supports continued access to its products for physicians and patients in Europe and worldwide.
SMT Leadership Highlights Quality and Clinical Evidence
Bhargav Kotadia, Chief Executive Officer of Sahajanand Medical Technologies, described the certification as a milestone that reflects the company’s approach to product development, regulatory compliance, and quality management.
Kotadia said the certification demonstrates the technical diligence, clinical evidence, and quality discipline that SMT’s teams apply to its medical devices. He also emphasized the importance of maintaining reliable support and continuity of care for physicians and patients who rely on Supraflex Cruz.
According to Kotadia, the certification reinforces SMT’s commitment to supporting healthcare professionals and patients while contributing to the company’s broader ambition of becoming a global leader in cardiovascular care.
The CEO’s comments highlight the role of regulatory compliance in the company’s strategy, particularly as it seeks to maintain access to established markets and strengthen its international presence.
Abhijeet Singhvi, Chief Technology Officer of SMT, said the EU MDR certification process reflects the increased requirements for clinical evidence, technical documentation, and post-market surveillance under the European regulatory framework.
Singhvi explained that obtaining the certification required collaboration among teams working in research and development, clinical practice, quality management, and regulatory affairs. The process involved coordinating technical and clinical information to demonstrate that the product met the applicable requirements.
He added that the certification strengthens the technology, clinical evidence, and engineering discipline supporting SMT’s next phase of innovation and growth in Europe and other global markets.
The company’s leadership views the regulatory milestone as part of its ongoing work to develop and support cardiovascular medical technologies while maintaining compliance with international standards.
About Sahajanand Medical Technologies Limited
Sahajanand Medical Technologies Limited is a medical technology company that develops and manufactures medical devices for vascular and structural cardiac interventions. Its portfolio includes technologically advanced products designed to support procedures involving the cardiovascular system, with a particular focus on vascular intervention.
SMT has established an international presence, with its products represented in more than 75 countries as of March 31, 2025. The company serves healthcare markets through a portfolio of devices designed for use in interventional cardiology and related medical procedures.
SMT was the first company worldwide to receive CE marking for a drug-eluting stent featuring a biodegradable polymer, according to the company. Its product portfolio includes coronary stent technologies developed for the treatment of vascular conditions.
The company continues to focus on clinical evidence, engineering, product quality, and regulatory compliance as part of its efforts to support cardiovascular care across international markets.
Additional information about Sahajanand Medical Technologies is available on its official website, www.smtpl.com , and its LinkedIn page.Sahajanand Medical Technologies Limited has stated that it intends, subject to the necessary approvals, market conditions, and other considerations, to conduct an initial public offering (IPO) of its shares.
The company filed a Draft Red Herring Prospectus (DRHP) dated July 25, 2025, with the Securities and Exchange Board of India (SEBI) and the stock exchanges. The document is available on the company’s website and on the websites of SEBI, Motilal Oswal Investment Advisors Limited, Avendus Capital Private Limited, HSBC Securities and Capital Markets (India) Private Limited, Nuvama Wealth Management Limited, and the National Stock Exchange of India (NSE) and BSE Limited.
Potential investors should be aware that investing in shares carries a high degree of risk. Investors are advised to review the Red Herring Prospectus, when available, particularly the section titled “Risk Factors,” before making investment decisions. Investment decisions should not be based solely on the DRHP.
The company has also stated that the original language in which the announcement was published is the official and authorized version. Any translations are provided for convenience, and the original-language version remains legally valid.
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