Amplatzer™ TorqVue™ LP Delivery System - Cardiac occluder delivery kit

Intended purpose

The Amplatzer™ TorqVue™ LP Delivery System is intended to facilitate the attachment, loading, delivery, and deployment of occluders. The Amplatzer™ TorqVue™ LP Delivery System is indicated to facilitate the delivery of a transcatheter occluder into the heart of patients with a patent ductus arteriosus.

Functional description

The Amplatzer TorqVue LP Delivery System is prepared for use by flushing with sterile saline and connecting the hemostasis valve to the delivery catheter with an extension tube and stopcock. After advancing this assembly over a guidewire to the desired location, the guidewire is removed. The occluder is prepared as per instructions for use and advanced through the delivery catheter to the treatment site. Once placement is confirmed, the occluder is released, and the delivery system is removed.