MicroPort® Coronary Announces FireShield™ Coronary Covered Stent System Enters NMPA Special Review Procedure for Innovative Medical Devices
Shanghai, China - July 30 - MicroPort® Coronary announced that its FireShield™ Coronary Covered Stent System has been included in the National Medical Products Administration (NMPA) special review procedures for innovative medical devices in China, commonly referred to as the “Green Channel.” This marks the sixth innovative medical device from MicroPort® Coronary to enter the special review procedure.
Coronary artery perforation or rupture is a rare but potentially life-threatening complication of percutaneous coronary intervention (PCI). Coronary covered stents are an established treatment option for managing selected coronary perforations when immediate vessel sealing is required. FireShield™ is a coronary covered stent system designed for the management of coronary artery perforation or rupture during PCI.
FireShield™ incorporates a single-layer cobalt-chromium alloy stent frame covered with an expanded polytetrafluoroethylene (ePTFE) membrane. The design is intended to reduce the system’s overall outer diameter and enhance deliverability and lesion-crossing capability, characteristics that may facilitate device delivery and deployment in time-sensitive clinical situations. The FireShield pivotal pre-market clinical study, CONVOY, completed full subject enrollment in July 20251.
The NMPA Green Channel designation provides FireShield™ with access to a special regulatory pathway, which includes dedicated regulatory communication and guidance during the registration process.
MicroPort® Coronary will continue to advance its cardiovascular interventional therapy portfolio with the aim of expanding treatment options for patients with coronary artery disease.
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 FireShield™ Coronary Covered Stent System has been included in the NMPA special review procedures for innovative medical devices in China. Inclusion in this procedure does not constitute marketing approval. FireShield™ has not yet been approved for marketing by the NMPA. Regulatory status varies by country and region. Healthcare professionals should refer to applicable local regulatory requirements and approved instructions for use.
Reference
- Chinese Clinical Trial Registry (ChiCTR). CONVOY Study. Enrollment completed July 2025; study ongoing/results pending.