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.”
