Device Dossier

BareWire Filter Delivery Wires - Peripheral vascular guidewire

Device Dossier for BareWire Filter Delivery Wires - Peripheral vascular guidewire (Peripheral vascular guidewire, Class III, sponsor Abbott Vascular…

Intended purpose

The device is designed to reduce distal embolization while maintaining blood flow during interventional procedures. The system is indicated for use during percutaneous transluminal angioplasty, and stenting procedures for patients with atherosclerotic disease in carotid arteries. The system is indicated for use during percutaneous transluminal angioplasty, atherectomy and stenting procedures for patients with atherosclerotic disease in the lower extremity arteries.

Functional description

The delivery wire is a PTFE coated stainless steel wire with a radiopaque shapeable distal tip section. It has zebra stripes on the proximal end for ease of identification. It may be used with the delivery catheter. The three delivery options provide access to diverse vascular anatomies and the radiopaque circumferential frame conveys vessel apposition and deployment status.

TGA Public Summary