News | May 27, 2007

Cordis Receives FDA Humanitarian Device Exemption for Vessel Reconstruction System

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

Related Content

Gore Announces First-in-Human Use of Gore TAG Conformable Thoracic Stent Graft
News | Stent Grafts| July 17, 2017
W. L. Gore & Associates Inc. announced the first patient implant of the Gore TAG Conformable Thoracic Stent Graft...
FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral| July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
Onyx DES 2.0 mm stent meets primary endpoints in small vessels
News | June 12, 2017
June 12, 2017 – The Medtronic Resolute Onyx Drug-Eluting Stent (DES) met its primary endpoint of target lesion failur
New Paper Highlights Success of Advanced Treatments in Complex Aortic Aneurysm Repair
News | Endovascular Aortic Repair| May 23, 2017
Significant success has been achieved in treating complex proximal aneurysms using a combination of fenestrated and...
First Pennsylvania Patient Treated in LEADERS FREE II Trial of BioFreedom Drug-Coated Stent
News | Stents Drug Eluting| May 12, 2017
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a trial assessing the safety and...
Resolute Onyx DES, drug eluting stent, medtronic, gains FDA approval
Technology | Stents Drug Eluting| May 01, 2017
May 1, 2017 — The U.S.
Sponsored Content | Videos | Stents Drug Eluting| May 01, 2017
This video, provided by Medtronic, demonstrates the Resolute Onyx coronary stent.
News | Stent Grafts| April 06, 2017
Endologix Inc. announced that the first patients were treated in the Expanding Patient Applicability with Polymer...
Tryton Medical, Side Branch Stent, first U.S. commercial case, New York-Presbyterian Hospital, Columbia University Medical Center
News | Stents Bifurcation| March 31, 2017
Tryton Medical Inc. recently announced that the first U.S. commercial case using the Tryton Side Branch Stent was...
Sponsored Content | Videos | Stents Bioresorbable| March 30, 2017
Stephen Ellis, M.D., professor of medicine and director of interventional cardiology at Cleveland Clinic, discusses t
Overlay Init