CARDIOFLOW-B (02160): ANCHORMAN left atrial appendage occluder system and its guiding system have obtained CE marking approval.
HeartConnect Medical (02160) announced that AnchorMan left heart...
CARDIOFLOW-B(02160) announces that the AnchorMan Left Atrial Appendage Closure System and its guiding system have obtained the CE mark (indicating certification that products sold within the European Economic Area meet health, safety, and environmental standards).
The AnchorMan Left Atrial Appendage Closure System and AnchorMan Left Atrial Guiding System are products independently developed by the company's subsidiary, Shanghai Zuoxin Medical Technology Co., Ltd. (Shanghai Zuoxin). The AnchorMan Left Atrial Appendage Closure System is expected to be used for percutaneous closure of the left atrial appendage to prevent left atrial thromboembolism.
The AnchorMan Left Atrial Guiding System is compatible with the AnchorMan Left Atrial Appendage Closure System and provides access to the femoral vein and interatrial septum. Both systems have been approved by the China National Medical Products Administration. The AnchorMan Left Atrial Appendage Closure System is currently the only approved semi-closed left atrial appendage closure device in China.
Furthermore, obtaining the CE mark approval for the AnchorMan Left Atrial Appendage Closure System and AnchorMan Left Atrial Guiding System signifies that their innovative R&D design and excellent clinical performance have reached international standards. This provides a prerequisite for entering the European structural heart disease market and offers strong support for expanding into more international markets. It is a crucial milestone in the company's development and globalization strategy, with the potential to broaden revenue sources, enhance global competitiveness, and bring more opportunities on the international stage, benefiting more patients with structural heart disease.
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