Amplatzer™ TorqVue™ Exchange System - Cardiac occluder delivery kit

Intended purpose

The Amplatzer™ TorqVue™ Exchange System is intended to facilitate the removal and exchange of a delivery sheath with one of equal or larger diameter to enable the recapture and replacement of an occluder.The Amplatzer™ TorqVue™ Exchange System is indicated to facilitate the removal and exchange of the Amplatzer Delivery Sheaths and delivery of an occluder into the heart of patients with heart defects.

Functional description

During the surgical procedure, if for any reason the occluder needs to be retrieved after deployment and a larger sheath is necessary, the Amplatzer™ TorqVue™ Exchange System is used. The Exchange System delivery cable is screwed to the in-situ delivery cable without losing contact with the delivery cable. The Delivery System sheath is removed, and the Exchange sheath/dilator assembly is advanced over the delivery cable. The occluder may then be retrieved and replaced as needed.