XACT Carotid Stent System – P040038/S043
This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.
Product Name: XACT Carotid Stent System
PMA Applicant: Abbott Vascular Inc.
Address: 3200 Lakeside Drive, Santa Clara, CA 95054
Approval Date: February 7, 2024
Approval Letter: Approval Order Statement
What is it?
The XACT Carotid Stent System is intended to be used to reopen narrowed parts of the carotid arteries in the neck that supply blood to the brain. The system consists of a delivery catheter and a self-expanding metal stent made of nitinol.
This approval expands the indications for the XACT Carotid Stent System to be used during a Transcarotid Artery Revascularization (TCAR) procedure, in which a device is placed in the neck instead of in the thigh in combination with the ENROUTE Transcarotid Neuroprotection System (ENROUTE NPS). The ENROUTE NPS temporarily reverses blood flow at the treatment area to redirect pieces that may become loose during the procedure from potentially traveling to the brain.
First, the ENROUTE NPS is placed with tubes in a person’s leg and neck and the tubes are connected by a flow controller (a device that controls the flow of liquids and gases). The ENROUTE NPS changes the direction of blood flow at the treatment point in the neck. After the ENROUTE NPS is in place, the doctor places the XACT delivery catheter into a person’s neck and moves the XACT Carotid Stent to the blocked area of the carotid artery. The XACT stent is then released from the catheter to automatically open the blood vessel over the blockage. The stent delivery catheter and ENROUTE NPS are both removed, and the stent remains permanently implanted in the artery and acts as a support for the newly opened section of the blood vessel.
The XACT Carotid Stent System is used with the ENROUTE NPS in people with moderate blockage in blood vessels (greater or equal to 50% or 70%, depending on a person’s symptoms), and those who qualify for a TCAR procedure based on their doctor’s review.
The stent opens blocked areas in the blood vessels to prevent future strokes. In real-world evidence collected from CREST-2 registry, 39 people were treated with the XACT Carotid Stent System in combination with the ENROUTE NPS System. All people with this device were successfully treated, and there were no observed harmful reactions or effects for this type of procedure.
The XACT Carotid Stent System should not be used in people who:
- Cannot take blood thinners or have uncorrected bleeding disorders.
- With a known allergy or hypersensitivity to stent materials (nickel-titanium alloy) or contrast medium (a substance to show one part against surrounding tissue), who cannot be medicated beforehand at an acceptable level.
- People in whom carotid bifurcation (point that divides into internal and external main arteries that supply blood to the brain) is less than five centimeters above the collarbone (ENROUTE Transcarotid NPS only).