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First-in-man experience with a new 7F vascular closure device (EXOSEAL™): the 7F ECLIPSE study
Marcus Wiemer1, Christoph Langer, Stephan Fichtlscherer
1Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany. marcus.wiemer@muehlenkreiskliniken.de
Journal of Interventional Cardiology
|July 6, 2012
Summary
The EXOSEAL™ Vascular Closure Device (VCD) demonstrated safety and effectiveness in a feasibility study, achieving rapid hemostasis and early ambulation for patients undergoing percutaneous procedures.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Current vascular closure devices (VCDs) offer faster times to hemostasis and ambulation than manual compression.
- However, variability exists in ease of use, patient comfort, and safety profiles of existing VCDs.
Purpose of the Study:
- To assess the feasibility, safety, and effectiveness of the EXOSEAL™ Vascular Closure Device (VCD).
- To evaluate the device's ability to achieve rapid hemostasis and enable early patient ambulation following percutaneous procedures.
Main Methods:
- A prospective feasibility study involving 60 patients undergoing procedures with 7F introducer sheaths.
- Primary endpoints included 30-day access-related complications, time-to-hemostasis (TTH), and time-to-ambulation (TTA).
Main Results:
- High device (92%) and procedural (93%) success rates were observed.
- Mean TTH was 3.2 minutes and mean TTA was 3.0 hours.
- No deaths or serious access-related complications occurred; one minor hematoma was reported in 3 patients.
Conclusions:
- The 7F EXOSEAL™ VCD is safe and effective for percutaneous procedures.
- It facilitates short TTH and TTA with a low complication rate.
