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Related Experiment Videos

Microvena atrial septal defect occlusion device--update 2000.

M P O'Laughlin1

  • 1Division of Cardiology, Department of Pediatrics, Duke University Medical Center, 3090, Durham, NC 27710, USA.

Journal of Interventional Cardiology
|June 11, 2002
PubMed
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.

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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.

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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.