Pipeline™ Embolization Device - P100018
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™ Embolization Device
PMA Applicant: Chestnut Medical Technologies
Address: 173 Jefferson Drive, Menlo Park, CA 94025
Approval Date: April 6, 2011
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf10/p100018a.pdf
What is it? The Pipeline™ Embolization Device (PED) is a braided, platinum and nickel-cobalt chromium alloy, wire mesh cylindrical implanted device, which is placed within an artery in the brain to treat aneurysms. An aneurysm is a localized, blood-filled ballooning in the wall of a blood vessel.
How does it work? When placed across the opening (the “neck”) to the brain aneurysm, the PED is intended to redirect blood flow away from the aneurysm causing the blood that remains in the aneurysm to form a blood clot. This clot prevents rupture of the aneurysm and may also cause the aneurysm to shrink in size over time.
When is it used? The PED is intended to treat adults with large or giant, wide-necked brain aneurysms of the major artery supplying the front of the brain called the internal carotid artery. It is a less open (invasive) treatment, performed with the use of a catheter placed inside the blood vessel, compared to an open surgical procedure with the use of clips to block the aneurysm. It is an alternative to placing materials such coils or a liquid embolic to treat the aneurysm.
What will it accomplish? By causing the aneurysm to be completely blocked, treatment with PED is intended to reduce the likelihood of an aneurysm rupture or reduce the likelihood of an increase of the size of the aneurysm, which also increases its risk of rupturing . A successfully treated aneurysm will often shrink in size over time.
When should it not be used? The PED should NOT be used in patients with an active infection, in patients for whom the use of antiplatelet blood thinners, such as aspirin and clopidogrel is contraindicated, or in patients who have not received adequate antiplatelet therapy prior tothe procedure to place the PED.
Additional information : Summary of Safety and Effectiveness and labeling are available online.