Shanghai, China, 03 March 2025 – MicroPort^® CardioAdvent, a subsidiary of MicroPort^® CardioFlow, has received EU Medical Device Regulation (MDR) certification for its AnchorMan^® Left Atrial Appendage Closure System (AnchorMan^® LAAC system), securing market approval in just 14 months from registration (Registration Number: MDR 795462) . Its companion device, the AnchorMan^® Left Atrial Appendage Access System, also received approval.

Compared to open and closed left atrial appendage occluders, the AnchorMan^® LAAC system integrates the advantages of both. Its semi-closed structure, featuring 12 “3D folding” units and an advanced frame design, addresses key challenges associated with deep sheath placement in conventional plug-in closure systems while ensuring stable anchoring. The device’s rounded, soft distal end minimizes trauma to LAA tissue, while its dense NiTi alloy frame design ensures tight conformity to the LAA anatomy, providing superior sealing performance. Additionally, its two deployment options - advancement and unsheathing - offer physicians more flexibility during procedures.

In May 2023, the results of the pre-market clinical study SAFE PROTECT – a prospective, multicenter, head-to-head randomized controlled trial - were unveiled for the first time at the European Congress of Percutaneous Cardiovascular Interventions (Euro-PCR). The study successfully reached its primary endpoint and secondary efficacy endpoints within one year, with results showing low incidences of stroke, systemic embolism, major bleeding, transient ischemic attack (TIA), device-related complications, and device-related thrombus (DRT) among patients. This notably high clinical success rate and low adverse events at one year are attributed to its innovative design.

The successful EU certification of both the AnchorMan^® LAAC system and its access device paves the way for MicroPort^® CardioFlow’s expansion into the European market, reinforcing its commitments to stroke prevention in patients with atrial fibrillation. 

Jeff Lindstrom, President of MicroPort^® CardioFlow, stated, “This certification is a major milestone in our global journey. We remain dedicated to driving innovation, overcoming technological barriers, and expanding our interventional therapy portfolio to provide more comprehensive solutions for patients worldwide.”

Guoming Chen, Chairman of MicroPort^® CardioFlow, commented, “Following the success of VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System, AnchorMan^® LAAC system and its access system represent our second major entry into the EU market. As these products gain traction across Europe, they will create strong synergies, further enhancing brand recognition and market share, and jointly elevating our international presence.”