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: FLAIR Endovascular Stent Graft
PMA Applicant: Bard Peripheral Vascular
Address: 1625 West 3rd Street, Tempe, AZ 85280-1740
Approval Date: July 23, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060002a.pdf
What is it? The FLAIR Endovascular Stent Graft is used to treat a stenosis, a narrowing or blockage, which has developed at the connection of a vein and an arteriovenous (A-V) access graft, known as the venous anastomosis. An A-V access graft acts as an artificial blood vessel that can be used repeatedly to draw blood with a needle during hemodialysis. The FLAIR Endovascular Stent Graft is a flexible, self-expanding tube made of ePTFE (expanded polytetrafluoroethylene) and a metallic support structure known as a stent, which holds the device open within the vein and A-V access graft. The stent graft is compressed into the end of a long, thin, tube-like device called a delivery catheter so that it can be implanted in the body.
The FLAIR Endovascular Stent Graft is the first endovascular system approved to treat a stenosis at the venous anastomoses of an A-V access graft.
How does it work? The FLAIR Endovascular Stent Graft is used after balloon inflation is performed to open the narrowed segment in the A-V access graft. The delivery catheter containing the endovascular graft is inserted into the A-V access graft and placed across the narrowed segment that has just been opened with the balloon. The endovascular graft is then released and self-expands so that it is pressing against the A-V access graft and blood vessel to keep the area open.
When is it used? The FLAIR Endovascular Stent Graft can be used to support or hold open a narrowed or blocked area at the connection of the A-V access graft and natural blood vessel. The FLAIR Endovascular Stent Graft is used instead of two other treatment options: 1) balloon angioplasty alone to open the narrowed segment or blockage in the A-V access graft; or 2) surgery to remove the blockage.
What will it accomplish? Use of the FLAIR Endovascular Stent Graft will restore blood flow at the venous anastomosis of an A-V access graft and keep the area open longer compared to treatment with balloon angioplasty alone.
When should it not be used? There are no known contraindications to use of the FLAIR Endovascular Stent Graft.
Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p060002