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Consumer Information on: RX Acculink Carotid Stent System - P040012/S034

Thu, 05/12/2011 - 8:39am
U.S. Food & Drug Administration

This is a brief overview of information related to 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 FDA’s approval.

Product Name: RX Acculink Carotid Stent System

PMA Applicant: Abbott Vascular

Address: 3200 Lakeside Drive, Santa Clara, CA 95054

Approval Date: May 6, 2011

Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf4/p040012s034a.pdf

What is it? The RX Acculink Carotid Stent System consists of the Acculink self-expanding carotid stent mounted on the Rapid Exchange (RX) delivery system and is used to re-open narrowed (stenotic) regions of the carotid arteries in the neck which supply blood to the brain. The stent is an implant constructed of nickel-titanium alloy (nitinol) tubing, laser-cut into a mesh shape. The stent is mounted onto the delivery catheter; a long, thin, tube-like device.

Carotid stents are typically used in conjunction with catheter-mounted filters or balloons that are placed near the treatment site to capture blood clots or plaque debris that may break off from the blockage during the stenting procedure (embolic protection devices). This material could block blood flow to the arteries beyond the narrowing and be harmful to the brain.

The RX Acculink Carotid Stent System is designed to be used with the Abbott Vascular family of Accunet or Emboshield embolic protection devices.

How does it work The RX Acculink Carotid Stent System is inserted during angioplasty (a less invasive procedure than surgery), in which the stent is threaded up to the carotid artery via a catheter inserted in the groin.

  • The embolic protection device is inserted into the vessel in the groin and advanced up to the blood vessel in the neck where there is blockage.
  • The embolic protection device is deployed, whereby the device is activated so that it will capture debris generated during the stenting procedure.
  • After the embolic protection device is deployed, the physician uses the same wire to advance the Acculink stent to the blocked area.
  • The stent is then allowed to come out of the catheter and opens automatically over the blockage.
  • The catheter is removed, and the embolic protection device is removed next, along with any pieces of debris that were trapped.

When is it used? The RX Acculink Carotid Stent System used in conjunction with one of Abbott Vascular’s Accunet or Emboshield family of embolic protection systems is used in patients who:

  • would have a high likelihood of complications due to other medical problems or body abnormalities if they had the surgical alternative (called carotid endarterectomy), and:
  • have had a recent stroke and have at least a moderate (greater or equal to 50%) blockage in the blood vessels of the neck, or
  • have not had a recent stroke but have a very tight (greater or equal to 80%) blockage in the vessels of the neck;

OR

  • would have a normal likelihood of complications if they had the surgical alternative (carotid endarterectomy), and:
    • have had a recent stroke and have at least a moderately tight (greater or equal to 70% or greater than or equal to 50% depending on the technique the physician uses to look at the blocked vessel) blockage in the blood vessels of the neck, or
    • have not had a recent stroke but have at least a moderately tight (greater than or equal to 70% or greater than or equal to 60% depending on the technique the physician uses to look at the blocked vessel) blockage in the vessels of the neck.

What will it accomplish? The stent is supposed to open blockages in the blood vessel in order to prevent future strokes. A clinical study included 2502 patients having a normal likelihood of complications if they had the alternative surgical treatment (carotid endarterectomy). In this study, about half of the patients were treated with an Acculink stent and the other half had surgery (carotid endarterectomy). The clinical study found that the risk of death, stroke and heart attack at 30 days after the procedure, plus the risk of stroke on the same side of the body as the blockage at one year after the procedure, was similar for both groups of patients. In addition, the study showed that the stent still allowed blood flow to the brain more than one year after the procedure.

When should it not be used? Stents should not be used in patients who:

  • have a narrowed area in their neck artery located beyond sharply curved vessels, making it difficult to place the stent and embolic protection device.
  • cannot take medicines that make their blood take longer to form a clot (anticoagulants).
  • cannot take medicines that make it harder for cells in their blood to form a blood clot (antiplatelets).
  • are allergic to nickel­-titanium, the metal used to make the RX Acculink Carotid Stents.
  • have an uncorrected bleeding disorder.
  • have blockages (lesions) at the opening/beginning of the neck artery, or
  • are allergic to dye (contrast).

Additional information : Summary of Safety and Effectiveness and labeling are available online. 

Other Resources:

 

SOURCE

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