FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Neuroform™ Microdelivery Stent System
Manufacturer: SMART Therapeutics, Inc.
Address: 2551 Merced Street, San Leandro, California 94577
Approval Date: September 11, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/h020002a.pdf
What is it? The Neuroform™ Microdelivery Stent System is designed to prevent the rupture of an aneurysm in the brain (an intracranial aneurysm). An aneurysm is formed by an abnormally weakened area in an artery wall. As time passes, the weak area stretches to form a balloon-like bulge in the artery wall. Without treatment, the weakened area could rupture and hemorrhage.
The device consists of a stent and a delivery system. The stent is a small wire mesh in the shape of a tube that is permanently placed at the opening (neck) of the aneurysm. The delivery system consists of flexible tubes (catheters) used to carry the stent to the aneurysm for placement.
How does it work? The delivery system carries and delivers the stent to the aneurysm site. The stent is placed across the neck of the aneurysm. When the stent expands in place to conform to the inside of the artery wall, the delivery catheter is withdrawn. The physician then passes another catheter through one of the small openings in the mesh of the stent and slides small metal coils (called embolic coils) through this second catheter into the aneurysm. The coils block blood from going into the aneurysm to help prevent the aneurysm from rupturing, and the stent keeps the coils from falling out of the aneurysm sac.
When is it used? The Neuroform™ Microdelivery Stent System is for use with embolic coils for the treatment of wide neck intracranial aneurysms that cannot be treated by placing a metal clip around the aneurysm neck (surgical clipping).
What will it accomplish? The stent provides a barrier to hold the embolic coils within the aneurysm. The coils cause clotting that helps to block blood from going into the aneurysm and may help to keep it from rupturing.
When should it not be used? On patients who cannot take blood-thinning (antiplatelet and/or anticoagulation) drugs that help prevent blood-clotting.
Additional information: SSPB and Labeling: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=h020002