Abbott RX Acculink Carotid Stent System

Abbott Vascular RX Acculink Carotid Stent System (RX Acculink System) includes a self-expanding nickel-titanium stent pre-mounted on a rapid exchange stent delivery catheter. Radiopaque markers on the shaft mark the stent location.

The delivery system is comprised of a retractable sheath covering the stent during delivery, a radiopaque tip, an internal guide wire lumen, a handle assembly with a safety lock, and a pullback handle. Retracting the pullback handle removes the sheath and deploys the stent.

Upon deployment, the stent forms an open lattice, providing the scaffolding necessary to hold the artery open and ensure blood flow through the artery.

The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria:

• Patients with neurological symptoms and ≥50% stenosis of the common or internal carotid artery by ultrasound or angiogram
• Patients without neurological symptoms and ≥80% stenosis of the common or internal carotid artery by ultrasound or angiogram
  

Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

The RX Acculink Carotid Stent System is contraindicated for use in:

• Patients in whom anti-coagulant and / or anti-platelet therapy is contraindicated.
• Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system, or stent system.
• Patients with known hypersensitivity to nickel-titanium.
• Patients with uncorrected bleeding disorders.
• Lesions in the ostium of the common carotid artery.