Shanghai, China, 02 February 2024 - AnchorMan^® Left Atrial Appendage Closure System (AnchorMan^® LAAC System), developed by CardioAdvent^®, an associated company of MicroPort^® CardioFlow, recently obtained approval in China. Its companion product, the AnchorMan^® LAA Access System, had previously been approved in October 2023.

AnchorMan^® LAAC System comprises of a left atrial appendage (LAA) closure device and a delivery system. It is intended for patients with non-valvular atrial fibrillation who have a high risk of stroke (as indicated by a CHA2DS2-VASC score ≥2) and either have contraindications to long-term oral anticoagulation therapy, or still face a risk of stroke despite anticoagulant treatment.

AnchorMan^® LAAC System’s innovative design includes:

• A semi-closed structure (formed by the 12 “3D folding” units and the frame) facilitates the merits of an open and closed closure device. This helps achieve stable anchoring and solves the clinical pain point by minimizing LAA depth compared to the traditional plug-in closure device access sheath;
• A rounded and soft distal end that helps reduce damage to the LAA tissue;
• A dense NiTi alloy frame, facilitating tight conformity to the anatomy of the LAA and achieving better sealing performance;
• Two deployment models of advancement and unsheathe which provide more options for physicians.
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Additionally, AnchorMan^® LAAC System is available in six closure device diameters ranging from 20 mm to 35 mm, catering to a larger patient population.

AnchorMan^® LAAC System completed its clinical enrollment for the pre-market trial in September 2021. The study demonstrated that AnchorMan^® LAAC System's 12-month clinical outcomes achieved non-inferiority compared to its control group products in primary and secondary endpoints. In terms of occlusion effectiveness, the complete occlusion and minimal residual leakage rates (residual shunt < 3mm) at 12 months post-operation were superior to those of the control group products.

On 1 January 2024, MicroPort^® CardioFlow strategically acquired Shanghai CardioAdvent, further expanding its expertise in the structural heart disease treatment field. The approval of AnchorMan^® LAAC System marks MicroPort^® CardioFlow's official entry into the stroke prevention field. Additionally, a registration application for CE certification for the product was submitted at the end of 2023.

Mr. Jeff Lindstrom, President of MicroPort^® CardioFlow, stated: "The innovative design of the AnchorMan^® LAAC System, with its rounded distal end and semi-closed structure, combines the advantages of both open and closed occluders. Its impressive clinical results are promising. The recent approval will enable the company to grow its business to the rapidly expanding and large patient-base segment of non-valve related structural heart disease. This expansion is anticipated to contribute to an increase in revenue scale and an optimization of operational efficiency".

Mr. Guoming Chen, Chairman of MicroPort^® CardioFlow, stated: "This acquisition further deepens and expands MicroPort^® CardioFlow’s pipeline layout, which contributes to enhancing our global competitiveness. In the future, MicroPort^® CardioFlow will strive to provide total solutions for structural heart diseases and is dedicated to providing high quality therapeutic solutions to patients and physicians across the globe”.