CHICAGO — ExoSeal, a novel investigational biodegradable vascular closure device, displayed outstanding safety and efficacy in its pivotal phase III clinical trial, Dr. Shing-Chiu Wong reported at the annual meeting of the American College of Cardiology.
In a study in which 401 patients undergoing percutaneous procedures via a femoral approach were randomized 2-to-1 to ExoSeal or manual compression, the average time to hemostasis with the device was 4.4 minutes, compared with 20 minutes with conventional manual compression.
Time to ambulation in the multicenter ECLIPSE trial averaged 2.5 hours with ExoSeal versus 6.2 hours in controls, added Dr. Wong, director of cardiac catheterization laboratories at New York-Presbyterian Hospital and professor of medicine at Cornell University, New York. Dr. Wong is a consultant to Cordis, the developer of ExoSeal.
The safety end point was a 30-day composite of access site-related infection, vascular injury requiring surgical repair, or access site-related rebleeding. The rate was zero in both study groups.
ExoSeal is a device with a unique deployment mechanism that delivers a felt-like polyglycolic acid plug to the surface of the arteriotomy via the same 6-French arterial sheath used in the percutaneous procedure. The plug undergoes hydrolysis and is degraded to carbon dioxide and water via the Krebs cycle over a 3-month period.
Deployment of the device is a simple matter taking about 1 minute. The procedural success rate in the study was 91% with ExoSeal as well as with manual compression. By design, half of the participants in the trial underwent diagnostic catheterization and the other half had percutaneous intervention.
Roughly 6 million percutaneous procedures were performed last year in the United States, 90% using a femoral approach. Vascular closure devices were used in about one-third of these procedures.
Discussant Dr. Timothy A. Sanborn said he was particularly impressed by ExoSeal's performance in the roughly 12% of subjects at elevated risk of bleeding complications because they received a glycoprotein IIb/IIIa inhibitor. In that subgroup, the device resulted in a ninefold faster time to hemostasis, and it cut time to ambulation in half compared with manual compression.
He noted, however, that there is nothing to anchor the ExoSeal plug to the arterial puncture site, unlike the case with Angio-Seal and some other approved devices. He'd like to see more data providing reassurance that plug slippage isn't a problem. Other than that, the device has promise, he said.
“This new vascular closure device is certainly very attractive in terms of its safety and efficacy and ease of use. It also has the advantage of not having an intraluminal component. You could hypothesize that compared to currently available vascular closure devices it may be more useful in patients with peripheral vascular disease or where the arteriotomy is right at the femoral bifurcation,” observed Dr. Sanborn, professor of medicine at Northwestern University, Chicago, who reported that he had no relevant conflicts of interest.