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: Flow Re-Direction Endoluminal Device (FRED®) System
PMA Applicant: MicroVention, Inc.
Address: 35 Enterprise, Aliso Viejo, CA 92656
Approval Date: December 16, 2019
Approval Letter: Approval Order
What is it? The FRED® System uses a permanent metal wire stent to provide support for a weakened area in a blood vessel in the brain that has bulged or ballooned into a brain aneurysm. The FRED® System blocks off blood flow to the aneurysm.
How does it work? The tight wire mesh stent of the FRED® device is intended to reduce or stop blood flow into the aneurysm by diverting blood to flow past the aneurysm site. The stent is delivered to the target area using minimally invasive surgery through the femoral artery in the groin, and then is threaded via guidewires through blood vessels until it reaches the target artery.
When is it used? The FRED® System is indicated for the treatment of brain aneurysms in patients 22 years of age and older when the aneurysm is bulging on one side (saccular) or both sides of the vessel wall (fusiform). The device can be used when there is a wide entry point to the aneurysm area (a “neck” width 4 mm or wider or dome-to-neck ratio less than 2 mm) in certain regions of the internal carotid artery, which supplies blood to the brain, when the carotid artery’s diameter is between 2 mm and 5 mm.
What will it accomplish? The FRED® System is designed to prevent an existing aneurysm from getting bigger by stopping blood flow into the aneurysm. It also relieves the pressure that blood flow puts on the weakened blood vessel wall. The support of the FRED® stent in the blood vessel gives the damaged vessel the opportunity to repair itself around the stent and across the neck of the aneurysm (endothelialization) over time. Sometimes, the stent allows for closing off the aneurysm from blood flow (occlusion).
In a clinical study, 76 out of 135 (56.7%) patients within the FDA-approved indicated use population who were treated with the device had complete occlusion of the aneurysm within one year of the procedure.
When should it not be used? The FRED® System should not be used in patients who:
- Are unable to take blood thinners (anti-coagulants or anti-platelet therapies) or who cannot take clot-busting (thrombolytic) drugs.
- Have a known metal hypersensitivity to metal jewelry or metals such as nickel-titanium.
- Have blood vessels or other anatomy that prevent the device system from passing through.
- Have an active bacterial infection.
- Already have a stent in place for the brain aneurysm.
- Have blood vessels that are larger or smaller than the size indicated for using the system.
- Have not received drugs that prevent clotting before the procedure (anti-platelet agents).
Additional information (including warnings, precautions, and adverse events):