Device Dossier

Amplatzer™ TorqVue™ Delivery System - Cardiac occluder delivery kit

Device Dossier for Amplatzer™ TorqVue™ Delivery System - Cardiac occluder delivery kit (Cardiac occluder delivery kit, Class III, sponsor Abbott…

Intended purpose

The Amplatzer™ TorqVue™ Delivery System is intended to facilitate the attachment, loading, delivery and deployment of occluders.The Amplatzer™ TorqVue™ Delivery system is indicated to facilitate the delivery of an occluder into the heart of patients with heart defects.

Functional description

Amplatzer™ TorqVue™ Delivery System is a sterile, single-use device designed to deliver transcatheter devices to specific anatomical locations in cardiovascular system. The procedure involves inserting and locking the dilator into a sheath, advancing the sheath/dilator assembly over an intravascular guidewire, and then connecting a hemostasis valve. An Occluder is attached to the distal end of the delivery cable, retracted into the loader, and then moved through the sheath to the treatment site.

TGA Public Summary