Cordis Receives FDA Humanitarian Device Exemption for Vessel Reconstruction System

 

May 28, 2007

May 29, 2007 — The FDA has cleared the CORDIS ENTERPRISE Vascular Reconstruction Device and Delivery System under the Humanitarian Device Exemption — it 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.

Product and indication details include:

• 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.

The CORDIS ENTERPRISE is intended for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms. The stent serves as a scaffold for embolic coils to prevent herniation of the coils into the parent vessel.

The device should not be used in patients who or in whom:

• 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

For more information visit www.fda.gov/cdrh/pdf6/h060001b.pdf