Recently, CFDA approved, upon review, the registration of the “left appendage occluder system” produced by LifeTech Scientific (Shenzhen).
The product comprises of two parts: left appendage occluder and conveyor. The former comprises a seal disc and a fixing disc. The product is mainly designed for non-valvular atrial fibrillation patients who have a higher stroke risk and have a stroke risk even after oral administration of anticoagulant or anticoagulant therapy and helps avoid or reduce stroke risks caused by the dropping of thrombus inside the left appendage.
The structure design of the product allows for repeated locations during surgeries, which is good for sealing the oral area of the left appendage and reducing the risk of the product dropping off. As the first domestically made left appendage sealing product approved into the market, it provides more options for the patients.
Food and Drug Administrations will strengthen the post-market supervision to the product to ensure the safe use of the device.