Recently, the innovative product "left atrial appendage occluder system” of Hangzhou Deno Electrophysiology Medical Technology Inc. is approved for marketing by China NMPA.
The left atrial appendage occluder system consists of a left atrial appendage occluder and a delivery device, in which the left atrial appendage occluder is connected by a sealed disc and an anchoring disc. The delivery device is composed of a delivery sheath, a dilator, a loader, a delivery cable and a hemostasis valve. The design of the sealed disc and the anchoring disc of the product adopts an innovative patented design, which makes full use of the self-expanding of the NiTi wire braid structure, and can meet the clinical needs of different forms of left atrial appendage occlusion to a certain extent.
This product is indicated for patients with nonvalvular atrial fibrillation who are at risk for stroke (CHA2DS2-VASc score ≥2) and who are contraindicated to long-term oral anticoagulation. The marketing of the product is expected to benefit more patients.
The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.