Pipeline Flex Embolization Device - P100018/S015
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: Pipeline Flex Embolization Device
PMA Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Address: 9775 Toledo Way
Irvine, California 92618
Approval Date: December 14, 2018
Approval Letter: Approval Order
What is it? The Pipeline Flex Embolization Device ("Pipeline Flex") is a permanent mesh cylinder (stent) braided from platinum and tungsten and cobalt-chromium-nickel alloy wires intended for the treatment of brain aneurysms that bulge or balloon out the sides of the blood vessel (wide-neck and fusiform). The Pipeline Flex also includes a guidewire-based delivery system used to place the implant inside the patient.
The current application expands the Pipeline Flex's indications for use to include treatment of small or medium wide-neck (neck width 4 mm or wider or dome-to-neck ratio less than 2) saccular or fusiform (elongated, spindle shaped aneurysm involving the entire vessel) brain aneurysms and involve the vessel that supplies blood to the brain (internal carotid artery).
How does it work? The delivery system containing the Pipeline Flex is first inserted into a blood vessel (femoral artery) in the upper leg (groin) through a small cut. The delivery system is carefully guided to the site of the aneurysm and released so that the Pipeline Flex restricts and diverts blood from entering the sac of the brain aneurysm, and helps to promote clotting over time.
When is it used? The Pipeline Flex Embolization Device is indicated for the treatment of brain aneurysms in patients 22 years of age and older. The device is intended to treat small or medium brain aneurysms with a wide-neck (neck width 4 mm or wider or dome-to-neck ratio less than 2) saccular or fusiform (elongated, spindle shaped aneurysm involving the entire vessel) aneurysms in the internal carotid artery with a vessel diameter between 2 mm and 5 mm. The device is also intended to treat large or giant brain aneurysms with a wide-neck in certain regions of the internal carotid artery.
What will it accomplish? In a clinical study of 134 patients, 78.98% of patients who were treated with the device achieved a successful treatment (complete occlusion) of their brain aneurysm within 1 year post-procedure without re-treatment or clinically significant narrowing of a blood vessels (in-stent stenosis).
When should it not be used? The Pipeline Flex Embolization Device should not be used in patients:
- With an active bacterial infection.
- Who are unable to take blood thinner medications such as aspirin and clopidogrel (dual antiplatelet therapy).
- Who have not received dual antiplatelet medication prior to the procedure.
- Who have a stent in place in the parent artery at the target aneurysm location.
Additional information (including warnings, precautions, and adverse events):