Amplatzer™ Trevisio™ Intravascular Delivery System - Cardiac occluder delivery kit

Intended purpose

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

Functional description

The delivery system is sterile, single-use and 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.