The special review procedures aim to accelerate review for innovative medical devices that meet criteria for domestic originality, technical novelty and clinical value. (The FDA Investigational Device Exemption program plays a similar role in the U.S.)
The FireShield system is a “designed for the management of coronary artery perforation or rupture during percutaneous coronary intervention,” MicroPort said.
FireShield is composed of a single-layer cobalt-chromium alloy stent frame covered in an expanded polytetrafluoroethylene (ePTFE) membrane. The device is currently undergoing a pre-market clinical study, which completed enrollment in July 2025.
The FireShield’s design “is intended to reduce the system’s overall outer diameter and enhance deliverability and lesion-crossing capability,” the company stated in a press release.
This is MicroPort’s sixth medical device to enter this special review process.
If approved, FireShield would enter into a category defined globally by Abbott’s GraftMaster and Biotronik’s PK Papyrus. Similarly to FireShield, GraftMaster also features an ePTFE membrane, while PK Papyrus is polyurethane covered. FireShield’s single-layer design, however, is closer to Papyrus.
