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  1. Recently-Approved Devices

Neuroguard IEP® System – P240009

Neuroguard IEP Stent

This is a brief overview of information related to the FDA’s approval of this product.  See the Additional Information section for links to the Summary of Safety and Effectiveness Data (SSED) and product labeling.

Product Name: Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilatation Balloon System with Integrated Embolic Protection (Neuroguard IEP® System)
Company Name (PMA Applicant): Contego Medical Inc.
Address: 3801 Lake Boone Trail, Suite 100, Raleigh, NC, 27607
Approval Date: October 11, 2024
Approval Letter: Approval order

What is it?

The Neuroguard IEP® System is used to re-open partly blocked regions of the carotid arteries in the neck which supply blood to the brain. The system consists of a self-expanding stent (a small mesh tube), a delivery catheter (a long, thin, flexible tube used to position the stent in the artery), a balloon that presses the stent against the artery, and a small filter that captures any particles that might come loose when the balloon is inflated. The stent is made of nickel-titanium alloy (nitinol) tubing.

Although the Neuroguard IEP System has a small filter in it, the system should always be used with a separate (commercially available) primary filter device. The primary filter device has holes to allow blood to flow through, but the holes are small enough to catch any particles that may break off from the blockage during the operation.

  • First, the doctor inserts the primary filter device into the artery in the groin and advances it up to the artery in the neck where there is blockage. They open the primary filter after placed in position.
  • After the primary filter device is in place, the doctor inserts the Neuroguard IEP System delivery catheter into the leg and moves the stent to the area in the neck where this is blockage.
  • The doctor opens the Neuroguard IEP System’s small filter like an umbrella before the stent is released from the catheter and opens automatically over the blockage.
  • The doctor inflates the Neuroguard IEP System’s balloon to help push the stent against the artery wall and then deflates it.
  • The doctor closes the Neuroguard IEP System’s small filter.
  • The doctor removes the delivery catheter and the primary filter device catheter.
  • The stent is the only part that remains permanently implanted in the neck artery and acts as a support for the newly opened section of the artery.

The Neuroguard IEP System is used along with a commercially available primary filter protection device in patients who have any of the following:
 

  • a high likelihood of complications due to other medical problems or body abnormalities if they had the surgical alternative (called carotid endarterectomy)
  • no recent stroke and a very large (80% or greater) blockage in the arteries of the neck
  • a recent stroke and at least a moderate (50% or greater) blockage in the arteries of the neck


The stent opens blockages in the artery to prevent future strokes. In a clinical study, the stent was implanted successfully in 293 out of 305 patients in the United States, with four (4) patients suffering a stroke.

The Neuroguard IEP System should not be used in patients:

  • who cannot take blood thinners or who have bleeding disorders
  • who are allergic to nitinol
  • who have problems preventing the Neuroguard IEP System catheter from getting to the blockage

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