Abbott XACT Carotid Stent System

Abbott Vascular Xact Carotid Stent System is comprised of a delivery system and a self-expanding stent. The delivery system is a rapid exchange (RX) system designed to deliver the self-expanding stent to the carotid vasculature.

The self-expanding stent is cut from Nitinol tube into a flexible tubular prosthesis. Upon deployment of the stent into the carotid vasculature via the delivery system, the stent should appose the vessel wall and apply an outward pressure to establish patency.

The Xact stent is available in both tapered and straight configurations, with diameters ranging from 6 mm through 10 mm. Stent lengths range from 20 mm through 40 mm.

The delivery system has an outer diameter (OD) of 5.7 Fr and is compatible with 8 Fr guiding catheter or a 6 Fr sheath - with a 0.088” inner diameter or greater. The delivery system has a working length of 136 cm.

Abbott Vascular Xact Carotid Stent System (Xact), used in conjunction with the Emboshield Embolic Protection System, is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the following criteria:

1. Patients with symptomatic carotid artery stenosis with ≥ 50%  occlusion on ultrasound or angiography.
2. Patients with asymptomatic CAS with  ≥ 80%  occlusion on ultrasound or angiography

Patients must have a reference vessel diameter ranging between 4.8 mm and 9.1 mm at the target lesion.

Abbott Vascular Xact Carotid Stent System (Xact) is contraindicated in, but not limited to, the following situations:

• Patients in whom anticoagulant and / or antiplatelet therapy is contraindicated.
• Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of the Guiding Catheter / Introducer Sheath, BareWire, Emboshield Delivery Catheter, Filtration Element, and / or Retrieval Catheter.
• Patients with a known hypersensitivity to nickel-titanium.
• Patients with uncorrected bleeding disorders.
• Lesions in the ostium of the common carotid artery.