FDA Approves XACT Carotid Stent System

A Breakthrough for Stroke Prevention 

Abbott Vascular Inc. has received FDA approval for its groundbreaking XACT Carotid Stent System, a significant advancement in stroke prevention technology. Approved on February 7, 2024, this innovative system offers new hope for individuals at risk of stroke due to narrowed carotid arteries. 

What is it?  

The XACT Carotid Stent System is designed to address narrowed sections of the carotid arteries in the neck, crucial blood vessels that supply blood to the brain. This system comprises a delivery catheter and a self-expanding metal stent made of nitinol. 

How does it work?  

During a Transcarotid Artery Revascularization (TCAR) procedure, the ENROUTE Transcarotid Neuroprotection System (ENROUTE NPS) is placed in the neck alongside the XACT Carotid Stent. The ENROUTE NPS temporarily redirects blood flow to prevent loose pieces from traveling to the brain during the procedure.  

Subsequently, the XACT delivery catheter is inserted into the neck, and the stent is positioned at the blocked area of the carotid artery. Once released, the stent automatically opens the blood vessel over the blockage, providing permanent support. 

When is it used?  

The XACT Carotid Stent System is utilized in individuals with moderate blockage in blood vessels (greater or equal to 50% or 70%, depending on symptoms) who qualify for a TCAR procedure. 

What will it accomplish?  

By opening blocked areas in the blood vessels, the XACT Carotid Stent System aims to prevent future strokes. Real-world evidence from the CREST-2 registry demonstrates the system’s efficacy, with all treated individuals experiencing successful outcomes and no observed harmful reactions or effects. 

When should it not be used?  

The XACT Carotid Stent System is contraindicated in individuals unable to take blood thinners or with uncorrected bleeding disorders.  

Additionally, it should not be used in individuals with known allergies to stent materials (nickel-titanium alloy) or contrast medium, or in cases where the carotid bifurcation is less than five centimeters above the collarbone. 

Summary 

This FDA approval marks a significant milestone in stroke prevention technology, offering a promising solution for individuals at risk of stroke due to narrowed carotid arteries.  

Links 

For more detailed information on the XACT Carotid Stent System, including indications for use and safety data, refer to the FDA’s Summary of Safety and Effectiveness Data (SSED) and product labeling available on the FDA website.