Device Dossier

Amplatzer™ TorqVue™ 2 Delivery Sheath - Cardiac occluder delivery kit

Device Dossier for Amplatzer™ TorqVue™ 2 Delivery Sheath - Cardiac occluder delivery kit (Cardiac occluder delivery kit, Class III, sponsor Abbott…

Intended purpose

The Amplatzer™ TorqVue™ 2 Delivery Sheath is intended to provide a pathway through which a device is introduced within the chambers and coronary vasculature of the heart.

Functional description

The Amplatzer™ TorqVue™ 2 Delivery Sheath consists of a sheath and a dilator packaged with each delivery sheath. The sheath has a straight shaft with a working length of 120 cm and provides a pathway through which a device is delivered. The body of the sheath is radiopaque for visibility under fluoroscopy. The dilator eases penetration of tissue and minimizes vessel trauma and facilitates passage of the sheath through the vessel to the intended site.

TGA Public Summary