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: CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System
Manufacturer: Cordis Neurovascular, Inc.
Address: 14000 N.W. 57th Court, Miami Lakes, Florida 33014
Approval Date: May 8, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/h060001a.pdf
What is it? The CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System is used with embolic coils for the treatment of intracranial aneurysms. It consists of a self-expanding stent and a delivery system. The stent serves as a scaffold for embolic coils to prevent herniation of the coils into the parent vessel. The stent is a self-expanding, metal (nitinol) mesh in the shape of a tube. The delivery system is composed of an introducer and delivery wire and is used to deliver the stent to the treatment site in the neurovasculature.
How does it work?
- Advance stent system through microcatheter.
- Position the stent by aligning the stent positioning marker of the delivery wire with the target site.
- Unsheath to deploy.
- Carefully retract the microcatheter, while maintaining the position of the delivery wire, to allow the stent to deploy across the neck of the aneurysm.
- The stent will expand as it exits the microcatheter.
- Maintain distal access.
- Exchange microcatheter for coiling procedure.
- Proceed with coiling procedure through stent cells.
When is it used? The CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System is intended for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms.
What will it accomplish? The stent serves as a scaffold for embolic coils to prevent herniation of the coils into the parent vessel.
When should it not be used? The CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System should not be used in patients who:
- the aneurysm size and/or parent vessel size does not fall within the indicated range
- cannot take blood-thinning (antiplatelet and/or anticoagulation) drugs to help prevent blood clots
- the angiography demonstrates the anatomy is not appropriate for endovascular treatment
SSPB and Labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=h060001