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September 4, 2026

MicroPort’s FireShield Coronary Covered Stent System Enters China’s NMPA Special Review Procedure

KEY TAKEAWAYS

  • MicroPort Coronary’s FireShield coronary covered stent system entered China’s NMPA special review procedure for innovative medical devices.
  • The covered stent is designed to manage coronary artery perforation or rupture during PCI.
  • The CONVOY pivotal premarket clinical study completed patient enrollment in July 2025.

September 4, 2026—MicroPort Coronary, a medical device company based in Shanghai, China, announced that its FireShield coronary covered stent system has been included in China’s National Medical Products Administration (NMPA) special review procedures for innovative medical devices (known as the “Green Channel”).

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, noted MicroPort.

According to the company, the FireShield system is designed for the management of coronary artery perforation or rupture during percutaneous coronary intervention (PCI). The system incorporates a single-layer cobalt-chromium alloy stent frame covered with an expanded polytetrafluoroethylene membrane.

MicroPort stated that the device’s design is intended to reduce the system’s overall outer diameter and enhance deliverability and lesion-crossing capability, characteristics intended to facilitate device delivery and deployment in time-sensitive clinical situations. In July 2025, the CONVOY pivotal premarket clinical study of FireShield, completed full patient enrollment. CONVOY is listed with the Chinese Clinical Trial Registry, advised the company.

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