Europe – April 2026 – MicroPort® Coronary, a subsidiary of MicroPort Scientific Corporation, announced that three of its core products have received certification under the European Union’s Medical Device Regulation (MDR) during March 2026. The certified products are the Firehawk® Sirolimus Target Eluting Coronary Stent System, the Firehawk Liberty® Sirolimus Target Eluting Coronary Stent System, and the Firefighter® NC PTCA Balloon Catheter.
Previously certified under MDD, these three products now meet the EU’s latest regulatory standards, bringing MicroPort® Coronary's total number of CE MDR-certified coronary intervention products to five. The Firefighter™ PTCA Balloon Dilatation Catheter and the ArgusScout™ OCT Imaging Catheter received CE MDR certification in 2023 and 2024 respectively..
MicroPort® Coronary has developed an integrated coronary intervention portfolio spanning the full treatment pathway, from precision imaging and lesion preparation to stent-based therapy. The ArgusScout™ OCT imaging system is available in multiple markets including Bangladesh and Singapore. The Firefighter™ balloon series is commercially available in South Korea, Brazil, France, and Kazakhstan, among other markets. The Firehawk® stent series has been the subject of clinical studies published in The New England Journal of Medicine1 and The Lancet2, and MicroPort® coronary stent systems have surpassed 10 million units shipped and implanted globally.¹
MicroPort® Coronary will continue to advance its coronary intervention portfolio and expand its global footprint, with the aim of delivering high-quality treatment solutions to benefit patients worldwide.
About MicroPort® Coronary
Shanghai MicroPort Medical (Group) Co., Ltd. (MicroPort® Coronary) was established on May 15, 1998, in Zhangjiang Science City, Shanghai, China. As the birthplace of the MicroPort® Group, the company specializes in providing products and services for the interventional treatment of coronary artery-related diseases. It has developed a
mature global network for research and development, production, marketing, and services. MicroPort® Coronary now has a presence in nearly 90 countries and regions, serving more than 3,000 hospitals. Forward-looking statement
This press release contains forward-looking statements based on current expectations. Actual results may differ materially from those anticipated. Statements regarding future product introductions, market expansion, and commercial activities reflect current plans and are subject to change.
Regulatory disclaimer
The Firehawk® Sirolimus Targeted Drug-Eluting Coronary Stent System, FireCondor® Coronary Stent System, and Firefighter™ NC PTCA Balloon Dilatation Catheter have received CE certification under the EU MDR. Regulatory status varies by country and region. Not all products or indications described in this release may be approved in all markets. Healthcare professionals should refer to applicable local regulatory requirements and instructions for use. References
1. Tarantini G, et al. Early Discontinuation of Aspirin after PCI in Low-Risk Acute Myocardial Infarction. N Engl J Med. 2025 August 31. DOI: 10.1056/NEJMoa2508808
2. Lansky, Alexandra et al. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial, The Lancet, Volume 392, Issue 10153, 1117 – 1126