Medical Tool Gets FDA Approval For Exoseal Vascular Closure Device

Cordis has received FDA approval for its Exoseal vascular closure device. The tool, used to close the femoral artery puncture site during diagnostic angiographies and interventional procedures, employs an absorbable plug to close the vessel wall. In a clinical trial comparing the Exoseal to the traditional alternative, prolonged manual compression or compression with a clamp or bag, the Exoseal resulted in shorter time to cessation of bleeding and an almost two-third reduction in time to ambulation. The device has been available in Europe, Asia and Latin America since June 2010.

Some more information on the workings of the device from the press release:

The EXOSEAL™ Vascular Closure Device makes use of key technological developments to support the clinical safety of the closure procedure. In the ECLIPSE Trial, the extravascular plug placement was associated with no embolization, infection or other major adverse events, comparable to manual compression [despite the significantly shorter time to ambulation for EXOSEAL™]. The bioabsorbable PGA-plug, which is designed to close the femoral artery puncture site with minimal or no inflammation, is fully reabsorbed in 60-90 days. PGA (Polyglycolic Acid) is a trusted non-collagen plug material that is metabolized to carbon dioxide and water. A system of deployment through the existing procedural sheath helps make EXOSEAL™ quick and easy to use, and increases physician convenience since there is no need for sheath exchange during the procedure. The device uses visual indicators to help the clinician deploy the device correctly. This “visual feedback” also promotes patient comfort during deployment by minimizing tugging and pulling and the ‘lock-out’ system of EXOSEAL™ helps clinicians to achieve proper extra-vascular plug placement.


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