title: First-in-man experience with a new 7F vascular closure device (EXOSEAL™): the 7F ECLIPSE study.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany. marcus.wiemer@muehlenkreiskliniken.de
authors: Marcus
authors: M
authors: Wiemer
authors: Christoph
authors: C
authors: Langer
authors: Stephan
authors: S
authors: Fichtlscherer
authors: Christian
authors: C
authors: Firschke
authors: Florian
authors: F
authors: Hofbauer
authors: Markus
authors: M
authors: Lins
authors: Michael
authors: M
authors: Haude
authors: Christof
authors: C
authors: Debèfve
authors: Hans-Peter
authors: HP
authors: Stoll
authors: Christoph
authors: C
authors: Hanefeld
mesh_terms: D006328:Cardiac Catheterization / Q000379:methods*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D004434:Early Ambulation; D057510:Endovascular Procedures; D004869:Equipment Safety; D005240:Feasibility Studies; D005260:Female; D006470:Hemorrhage / Q000517:prevention & control*; D006487:Hemostasis; D006489:Hemostatic Techniques; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D014463:Ultrasonography