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Related Experiment Videos

New self-expanding patent foramen ovale occlusion device.

Y M Han1, X Gu, J L Titus

  • 1Department of Radiology, The University of Minnesota, Fairview University Medical Center, Minneapolis, Minnesota 55455, USA.

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
|July 13, 1999
PubMed
Summary

A new self-expanding device effectively closes patent foramen ovale (PFO) in animal models. Complete occlusion was observed, with full endothelialization by three months, indicating high efficacy for PFO closure.

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Area of Science:

  • Cardiovascular Interventions
  • Medical Device Technology
  • Interventional Cardiology

Background:

  • Patent foramen ovale (PFO) is a common cardiac anomaly.
  • Transcatheter closure is an alternative to surgical intervention for PFO.

Purpose of the Study:

  • To evaluate a novel self-expanding nitinol device for patent foramen ovale (PFO) closure.
  • Assess the safety and efficacy of the PFO closure device in an animal model.

Main Methods:

  • A new self-expanding PFO closure device was implanted in minipigs with induced or naturally occurring PFOs.
  • Device placement success and PFO occlusion were assessed using pulmonary and right atrial angiography and echocardiography.
  • Histopathological examination was performed at 1 and 3 months post-implantation.

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Main Results:

  • Technical success was achieved in 6 out of 7 animals.
  • Complete PFO occlusion was confirmed in all successfully treated animals.
  • Histopathology revealed complete endothelialization of the device by 3 months.

Conclusions:

  • The self-expanding device demonstrates high efficacy and safety for patent foramen ovale closure.
  • The device's design and small delivery sheath suggest potential for outpatient procedures.
  • Complete endothelialization indicates good biocompatibility and long-term integration of the device.