Left atrial appendage closure occlusion device LeSifterTM

The left atrial appendage (LAA) Closure Device consists of the LAA occluder and a Access System (Delivery System and Guiding System), where the occluder is pre-loaded into the Delivery System. The Guiding System include a Dilation Tube and a Guiding sheath. The Occluder and Delivery system can be introduced through the femoral vein and passed across the atrial septum to reach the left atrium for placement of the occluder into the left atrial appendage. The occluder is made of self-expanding nitinol alloy material, with its outer surface covered by a porous mesh. The product is available in 5 size options, ranging from 20mm to 35mm. The appropriate size of the occluder is selected by measuring the size of the left atrial appendage orifice using fluoroscopy (fluoroscopic imaging) and transesophageal echocardiography (TEE). The LAA occluder is designed for permanent implantation at the orifice (opening) of the left atrial appendage or slightly distal to it, in order to intercept thrombus generated within the left atrial appendage. The implantation procedure is performed in the catheterization lab under local or general anesthesia. Intended Use LeSifterTM is intended for percutaneous, transcatheter closure of the left atrial appendage. Indications For Use The LesifterTM Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: • Are at increased risk for stroke and systemic embolism based on CHA2DS2-VASc1 scores and are recommended for anticoagulation therapy; • Are deemed by their physicians to be suitable for anticoagulation therapy; and