FDA Clears New Cordis Vascular Closure Device

 

June 10, 2011

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: www.cordis.com

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