Amplatzer™ Amulet™ Delivery Sheath - Cardiac occluder delivery kit

Intended purpose

The Amplatzer Amulet Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart. The Amplatzer™ Amulet™ Delivery Sheath is indicated to provide a pathway through which a left atrial appendage (LAA) occluder is delivered into the LAA in patients with non-valvular atrial fibrillation.

Functional description

Transseptal puncture is performed to access the left atrium. A guidewire is placed in the left upper pulmonary vein, and the dilator and delivery sheath are advanced. The occluder is delivered to the Left Atrial Appendage (LAA) under fluoroscopy and echocardiography. The lobe of the occluder is deployed in the LAA, and the disc covers LAA orifice. The occluder placement is confirmed, and the device is released by unscrewing the delivery cable and sheath from the patient.