Shanghai Pusci Medical Device's Innovative Left Atrial Appendage Closure System Receives NMPA Approval

Medical Network, May 7 — On May 6, the National Medical Products Administration issued a notice announcing that, following review, it had approved the registration of the innovative product “Left Atrial Appendage Occluder System” developed by Shanghai Push Medical Devices Co., Ltd.

 

This product consists of a non-preloaded left atrial appendage (LAA) occluder and an interventional delivery system. The LAA occluder comprises a cover disc, an occlusion pillar, a stainless steel sleeve, and a polyester flow-blocking membrane. The cover disc and occlusion pillar feature a modular design, connected by a stainless steel sleeve. This configuration ensures secure anchoring of the occluder while reducing tension on the cover disc, allowing it to conform more softly to the ostium of the left atrial appendage and thereby lowering the incidence of residual shunting. The interventional delivery system consists of a loader, a dilator, a delivery sheath, a pusher rod, and a flush connector.

 

This product provides a clinical treatment option for patients with non-valvular atrial fibrillation who have a CHADS2 score ≥1 and are not suitable for long-term anticoagulation therapy with warfarin, with the intended purpose of preventing stroke in patients with non-valvular atrial fibrillation.

 

　　PharmaceuticalsThe regulatory authorities will strengthen post-market surveillance of this product to ensure the safety of patients using medical devices.