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  1. Recently-Approved Devices

XACT Carotid Stent System – P040038/S043

XACT Carotid Stent System is used to reopen narrowed parts of the carotid arteries.

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.

 
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