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: INCRAFT® AAA Stent Graft System
PMA Applicant: Cordis Corp. (A Cardinal Health Company)
Address: 1820 McCarthy Blvd, Milpitas, CA, USA 95035
Approval Date: November 27, 2018
Approval Letter: Approval Order
What is it? The INCRAFT® AAA Stent Graft System is a multi-component system that consists of permanent implantable flexible fabric tubes each supported by a metal framework (stent graft), and a long thin tube used to place the stent graft (delivery catheter). The device is used to repair a weakened and bulging section (aneurysm) of the aorta (largest artery in the abdomen) below the renal arteries (infrarenal abdominal aorta).
How does it work? The delivery catheter containing the stent graft is inserted into the femoral artery (a blood vessel in the upper leg) through a small cut. The delivery system is carefully guided to the site of the aneurysm in the abdominal aorta and placed to provide a new flow path for blood flow. This relieves the pressure on the weakened and bulging section of the aorta (aneurysm), which may prevent further aneurysm growth, bursting (rupture) of the aneurysm, and death.
When is it used? The INCRAFT® AAA Stent Graft System is used in patients who have an abdominal aortic aneurysm of the infrarenal abdominal aorta and who have vessels in the upper leg that may be difficult to access with other delivery catheters (such as very small blood vessels in the leg).
What will it accomplish? The INCRAFT® AAA Stent Graft System may prevent further growth or rupture of the aneurysm. If the device does not completely seal off the aneurysm from blood flow, there is a chance that additional procedures will be needed to prevent growth or rupture of the aneurysm.
When should it not be used? The INCRAFT® AAA Stent Graft System should not be used in patients who:
- are not able to undergo the necessary pre- and post-operative imaging and implantation studies,
- have a known allergy or intolerance to the materials in the device (such as nitinol, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), tantalum, platinum-iridium alloy),
- have a condition (such as an active infection) that might threaten to infect the stent graft.
Additional information (including warnings, precautions and adverse events):