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Microvena atrial septal defect occlusion device--update 2000.
1Division of Cardiology, Department of Pediatrics, Duke University Medical Center, 3090, Durham, NC 27710, USA.
Journal of Interventional Cardiology
|June 11, 2002
Summary
The Das-Angel Wings device showed promise for atrial septal defect closure, with most patients achieving successful closure. Redesign led to the Guardian Angel device, offering improved features for future clinical trials.
Area of Science:
- Cardiovascular Medicine
- Medical Devices
- Interventional Cardiology
Background:
- Atrial septal defects (ASDs) are congenital heart conditions requiring closure.
- The Das-Angel Wings device was an early attempt at percutaneous ASD occlusion.
Purpose of the Study:
- To summarize Duke University's experience with the first-generation Das-Angel Wings ASD occlusion device.
- To outline the rationale for device redesign.
- To describe the characteristics and future plans for the new Microvena Guardian Angel device.
Main Methods:
- Retrospective review of 35 patients undergoing ASD closure with the first-generation device.
- Analysis of device placement, success rates, complications, and long-term follow-up.
- Description of design modifications and the new device's features.
Main Results:
- Successful device placement in 32 of 35 patients.
- Complete closure in 27 patients, with residual leaks in 5.
- No strokes, embolizations, or device-related deaths; follow-up to 63 months.
- Device malposition occurred in 3 patients, requiring intervention.
Conclusions:
- The initial device demonstrated feasibility but identified areas for improvement.
- Redesign focused on enhanced deployment, manipulation, and retrievability.
- The new Guardian Angel device incorporates these improvements and is poised for future clinical trials.