Cordis's ExoSeal Receives CE Mark Approval

May 27, 2010—Cordis Corporation (Bridgewater, NJ) announced that it has received CE Mark approval for the ExoSeal vascular closure device, which will be launched in Europe in June. The ExoSeal incorporates a polyglycolic acid (PGA) plug, two visual indicators to moderate control of the device, and lockout features to reduce the risk of complications.

Cordis stated that the bioabsorbable PGA plug is designed to close the femoral artery puncture site with minimal or no inflammation. It is fully reabsorbed in 60 to 90 days. PGA is a noncollagen plug material that is metabolized into carbon dioxide and water. A system of deployment through the existing procedural sheath allows for quick and easy use and minimizes the need for sheath exchange during the procedure. The device uses two visual indicators to help deploy the device correctly. ExoSeal's lockout system helps ensure that only extravascular plug placement can take place, the company stated.

According to Cordis, two nonrandomized studies conducted in Mexico and Germany assessed the safety and effectiveness of the device. In the United States, the 6-F ExoSeal was compared to manual compression with a 2:1 randomization in patients undergoing diagnostic and interventional coronary/peripheral procedures. The trials tested the time to hemostasis, the time to ambulation, and the 30-day combined rate of access site–related complications. The results showed that there were no major adverse events, vascular repair, access site–related bleeding requiring transfusion, access site–related infection requiring treatment, new ipsilateral lower extremity ischemia, or surgery for access site–related nerve injury.

The company stated that the ECLIPSE (Ensure's Vascular Closure Device Speeds Hemostasis) trial demonstrated that ExoSeal 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. Clinical data from the ECLIPSE trial indicated safety in terms of vessel injury, access site–related bleeding, infection or nerve injury, new ipsilateral lower extremity ischemia, or serious adverse events.

“From our experience in the ECLIPSE trial, we were impressed with the safety and the effectiveness of this new closure device,” commented Primary Investigator Marcus Wiemer, MD. “It is very easy to use, and nothing is left inside the vessel to threaten arterial blood flow. An advantage compared to other devices is that the procedural sheath does not need to be changed, which helps promote patient comfort. The two visual indicators are important for positioning the bioabsorbable plug.”