News | June 10, 2011

FDA Clears New Cordis Vascular Closure Device

June 10, 2011 – The U.S. Food and Drug Administration (FDA) granted market clearance for a new vascular closure device (VCD) that uses a bioabsorbable plug to seal femoral artery puncture sites. The Cordis Exoseal VCD is indicated for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional catheterization.

The device is indicated for procedures using a standard 5, 6 or 7 French vascular sheath introducer with up to 12 cm working length. Additionally, it is indicated to reduce times to hemostasis and ambulation in patients who have undergone interventional catheterization procedures, using a standard 6 French vascular sheath introducer up to a 12 cm working length, who have received preprocedural and/or intraprocedural glycoprotein (GP) Ilb/Ia inhibitor therapy.

The bioabsorbable plug is made entirely of a synthetic, absorbable polymer (polyglycolic acid – PGA). PGA material has been used extensively by the medical community since 1970, primarily with bioabsorbable sutures. The PGA plug material is constructed to stop bleeding from the puncture site. The plug delivery system is designed to position and release the bioabsorbable plug to seal the puncture site in the main artery of the thigh (femoral artery).

The plug uses a standard introducer sheath. To help with the positioning and deployment, the delivery system incorporates two unique markers that provide the surgeon with visual targets to determine the location of the plug relative to the outside of the vascular wall prior to initiating and deploying the plug.

For more information:

Related Content

The bioresorbable Cordis Mynx Grip vascular closure device seals arteriotomies without use of permanent hardware.

The bioresorbable Cordis MynxGrip vascular closure device seals arteriotomies without use of permanent hardware.

Feature | Vascular Closure Devices | January 22, 2018 | Dave Fornell
While manual compression remains the gold standard for hemostasis of catheterization vascular access site arteriotomi
Vivasure Enrolls First Patient in Frontier IV Clinical Trial
News | Vascular Closure Devices | December 29, 2017
Vivasure Medical announced in October the successful enrollment of the first patient in the Frontier IV clinical study...
Enrollment Completed in U.S. IDE Trial for Manta Large Bore Vascular Closure Device
News | Vascular Closure Devices | December 22, 2017
Essential Medical announced the completion of enrollment in the U.S. pivotal investigational device exemption (IDE)...
Vasorum Launches Celt ACD Second-Generation Vascular Closure Device in the U.S.
Technology | Vascular Closure Devices | December 14, 2017
Vasorum Ltd, the developer and manufacturer of the novel Celt ACD vascular closure device, has added a 7F-sized Celt...
angioseal, angio-seal, terumo, St. Jude, vascular closure devices
News | Vascular Closure Devices | October 18, 2016
October 18, 2016 — Abbott and St. Jude Medical Inc.
Vivasure Medical, Closure Device, Series C financing
News | Vascular Closure Devices | September 12, 2016
September 12, 2016 — Vivasure Medical announced last week that the company has completed a Series C financing of €16.
Rex medical, Closer Vascular Sealing System, VSS, vascular closure, bioresorbable vascular closure device

A close up view of the Rex Medical Closer Vascular Sealing System components.

Technology | Vascular Closure Devices | August 03, 2016
August 3, 2016 — The U.S.
Vivasure Medical, PerQSeal, vascular closure device, CE Mark
News | Vascular Closure Devices | January 18, 2016
Vivasure Medical announced Conformité Européenne (CE) Mark approval of the world’s first fully bioabsorbable...
News | Vascular Closure Devices | December 16, 2015
Scientists at CBSET have presented preclinical evidence that the Manta Large Bore Vascular Closure Device (VCD) from...
Videos | Vascular Closure Devices | September 26, 2014
Doug Drachman, M.D., Mass General Hospital Institute of Heart, Vascular and Stroke Care, explains how to prevent and
Overlay Init