We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
First-in-man experience with a new 7F vascular closure device (EXOSEAL™): the 7F ECLIPSE study.
- Authors
Wiemer M; Langer C; Fichtlscherer S; Firschke C; Hofbauer F; Lins M; Haude M; Debèfve C; Stoll HP; Hanefeld C; Wiemer, Marcus; Langer, Christoph; Fichtlscherer, Stephan; Firschke, Christian; Hofbauer, Florian; Lins, Markus; Haude, Michael; Debèfve, Christof; Stoll, Hans-Peter; Hanefeld, Christoph
- Abstract
<bold>Objective: </bold>This feasibility study examined safety and effectiveness of the new EXOSEAL™ Vascular Closure Device (VCD) designed to promote hemostasis and early ambulation after percutaneous procedures. <bold>Background: </bold>Most VCDs currently approved by the United States FDA have been associated with significantly shorter time-to-hemostasis (TTH) and time-to-ambulation (TTA) compared to standard manual or mechanical compression, but their ease of use, patient comfort during deployment, and safety profiles are variable. <bold>Methods: </bold>Patients underwent diagnostic or interventional procedures using 7F introducer sheaths. Primary safety endpoint was the 30-day combined rate of access-related complications and primary effectiveness endpoints were TTH and TTA. <bold>Results: </bold>Sixty patients were enrolled prospectively (mean age 63.3 ± 11.3 year, 17% diabetics). Device and procedural success was achieved in 92% and 93%, respectively. Mean TTH and TTA was 3.2 ± 3.0 minutes and 3.0 ± 6.2 hours, respectively. No deaths or serious access-related adverse events occurred. A ≥6 cm access-site hematoma was the only adverse event, observed in 3 patients. <bold>Conclusions: </bold>Use of the 7F EXOSEAL™ VCD was associated with short TTH and TTA, as well as low rates of procedural and 30-day access-related complications.
- Publication
Journal of Interventional Cardiology, 2012, Vol 25, Issue 5, p518
- ISSN
0896-4327
- Publication type
journal article
- DOI
10.1111/j.1540-8183.2012.00739.x