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: iCast Covered Stent System
PMA Applicant: Atrium Medical Corporation
Address: 40 Continental Boulevard, Merrimack, NH 03054
Approval Date: March 22, 2023
Approval Letter: Approval Order

What is it?

The iCast Covered Stent System is intended to treat narrowed blood vessels that supply blood to the pelvis and legs (iliac arteries). The system includes two parts: a small, spiral tube (stent) made of stainless steel wrapped in a polymer (ePTFE) and a delivery catheter. 

How does it work?

• A doctor inserts the iCast Covered Stent System’s delivery catheter into a blood vessel in the groin. 
• The stent is then positioned at the narrowed section of the iliac artery.
• After the catheter is in the right place, the stent expands and is pressed against the artery wall by inflating the balloon attached to the end of the catheter.
• The stent remains permanently implanted within the iliac artery, acting as a support (scaffold) for the newly opened section of the vessel and allowing normal blood flow to the leg.
• The delivery catheter, without the stent, is removed. 

When is it used?

The stent is used in people who have narrowed iliac arteries caused by atherosclerosis, the collection of fatty substances such as cholesterol that form “plaque” along the lining of the
arteries.

The iCast Covered Stent System is used to widen two specific iliac arteries, the native common and/or external iliac arteries, when those arteries are narrowed by plaque build-up associated with atherosclerosis. 

What will it accomplish?

The expanded stent opens the narrowed sections of the iliac arteries, allowing more blood flow to the legs. In a clinical study, approximately 154 out of 165 people (93.5%) who received the iCast Stent System to treat symptomatic atherosclerotic disease of the native common and/or external iliac arteries still had an open artery after one year.

When should it not be used?

The iCast Covered Stent System should not be used in people:

• Who have bleeding disorders or cannot take recommended medicines to thin the blood and prevent blood clots.
• With damage (lesions) to the blood vessels that will prevent the stent from being delivered or the angioplasty balloon from being fully inflated.
• With damage (lesions) to the blood vessels in locations where the stent would be compressed by something external, or outside the blood vessel. 

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• Labeling
• PMA Database Entry