MicroPort® Coronary's Firefighter™ Pro PTCA Balloon Catheter Receives FDA 510(k) Clearance

U.S.A – April 8 – MicroPort® Coronary, a subsidiary of MicroPort Scientific Corporation, recently announced that its Firefighter™ Pro PTCA Balloon Catheter has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), marking the company's third cleared product in the coronary segment in the U.S. market.

The Firefighter™ Pro builds on the foundational design of the CE MDR-certified Firefighter™ series and has been systematically optimized to support performance in complex coronary lesions. Key design enhancements include:

• Improved deliverability: Designed to reduce push rod size to enhance tracking and navigability through complex lesion pathways.
• Enhanced pushability: Surface redesign of the push rod is intended to streamline operability in challenging lesions.
• Comprehensive size range: Forty-five sizes covering diameters from 1.5 mm to 4.0 mm and lengths from 6 mm to 30 mm, intended to address diverse target lesion dimensions and reduce the need for device exchanges during procedures.

This clearance is part of MicroPort® Coronary's broader strategy to develop an integrated interventional coronary portfolio in the U.S., spanning imaging-guided PCI, lesion preparation, and stent-based therapy. The company is advancing FDA registration of additional core products, including intravascular imaging devices and drug-eluting stents.

MicroPort® Coronary remains committed to advancing innovations in coronary artery disease management and expanding access to quality coronary intervention solutions for 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.

Regulatory disclaimer

The Firefighter™ Pro PTCA Balloon Catheter has received 510(k) clearance from the U.S. FDA. All product and medical device market release information in this press release is for professional reference only and does not constitute any commitment or guarantee of market approval, performance, or safety in other countries or regions. The intended use, performance, and safety information of products in other countries or regions shall be subject to the registration certificates and instructions for use approved by the relevant local government authorities. Healthcare professionals should refer to applicable local regulatory requirements and instructions for use.