FDA Approves Cordis ExoSeal Vascular Closure Device

May 23, 2011—Cordis Corporation (Bridgewater, NJ) announced that the US Food and Drug Administration has approved the ExoSeal vascular closure device for use in the United States to provide precise and secure extravascular arterial closure. Cordis stated that the ExoSeal is due to be commercially available in the United States in June; it has been available in Europe, Asia, and Latin American markets since June 2010. The ExoSeal received CE Mark approval in May 2010, as reported in Endovascular Today.

According to the company, the safety and effectiveness of ExoSeal were assessed in the United States in the ECLIPSE trial, which compared the device with manual compression (MC) with a 2:1 randomization in patients undergoing diagnostic and interventional coronary/peripheral procedures. The trial tested the time to hemostasis, the time to ambulation, and the 30-day combined rate of access site-related complications.

Cordis noted that the device incorporates technological developments to support the clinical safety of the closure procedure. In the ECLIPSE trial, extravascular plug placement was associated with no embolization, infection, or other major adverse events, comparable to MC, even though there was significantly shorter time to ambulation for ExoSeal.

A bioabsorbable polyglycolic acid (PGA) plug is designed to close the femoral artery puncture site with minimal or no inflammation and is fully reabsorbed in 60 to 90 days. PGA is a noncollagen plug material that is metabolized to carbon dioxide and water. A system of deployment through the existing procedural sheath facilitates use of the device, and there is no need for sheath exchange during the procedure. The device uses visual indicators to guide deployment of the device and promotes patient comfort during deployment by minimizing tugging and pulling. The lockout system helps achieve proper extravascular plug placement.

Principal Investigator S. Chiu Wong, MD, commented, “From our experience in the ECLIPSE trial, this new closure device proved to be safe and effective. The results showed that the use of ExoSeal significantly reduced time to ambulation compared to MC. There were no major adverse events, no vascular repair, no access site-related bleeding requiring transfusion, and no access site-related infection requiring treatment. Based on these results, we believe that use of ExoSeal will benefit patients by shortening the time to ambulation, with a low rate of complications. In addition, the device has easy-to-use functionality.”