News:ExoSeal® Vascular Closure Device is safe and effective

April 1, 2008 By Alexandra M. Palmer [mailto:apalmer@perfuse.org]

The goal of this trial was to compare the safety and efficacy of the 6 French ExoSeal® extra-vascular closure device versus manual compression (MC) following sheath removal. In the test for superiority, the primary endpoints were time to hemostasis (TTH) and time to ambulation (TTA). The primary safety endpoint tested for non-inferiority was the 30-day combined rate of ischemia, infection, injury at the puncture site requiring medical or surgical treatment or bleeding requiring transfusion.

The ECLIPSE (Ensure’s Vascular Closure Device Speeds Hemostasis) trial was a randomized, multicenter study which included patients undergoing diagnostic and interventional coronary/peripheral procedures at 17 U.S. centers. 401 patients were randomized to one of two methods for closing the femoral artery access site: ExoSeal® bioabsorbable plug (n = 267) or MC (n = 134). Follow-up time was 30 days.

Compared to standard manual compression, the ExoSeal® device was associated with a significant reduction in both TTH (4.4 ± 11.6 vs. 20.1 ± 22.5 minutes, p<0.0001) and TTA (2.5 ± 5.0 vs. 6.2 ± 13.3 hours p = 0.028). The test for non-inferiority was void as there were no complications in either study arm.

The investigators concluded that a significant reduction in the TTH and TTA (primary effectiveness endpoints) was achieved in patients treated with the investigational ExoSeal® device compared with standard manual compression. The device was successfully deployed in about 1 minute on average following the procedure. There was no difference in procedural success or 30 day combined access site related complications rates between the two groups.

Further studies will compare the patient comfort level following deployment of the ExoSeal® to other vascular closure devices. Other areas of interest include the device’s effectiveness in treating patients whose puncture sites lie at or below the branch point of the femoral and iliac arteries.