title: Biodisk: a new device for closure of patent foramen ovale: a feasibility study in swine.
abstract: OBJECTIVE
  To evaluate the feasibility, effectiveness, and safety of a porcine small intestinal submucosa (SIS)-covered Biodisk (BD) for the closure of patent foramen ovale (PFO) in swine.
  
  
  METHODS
  Twelve piglets (9-30 kg) with PFO ranging in size from 6 to 12 mm were used for the in vivo testing. The BD device consisted of two basic nitinol wire components covered with platinum coil, a flexible SIS-covered ring, and an anchor. The BD was advanced through an 8-Fr sheath from the femoral vein. Nine acute animals were used to test the BD for deployment, stability, immediate shunt closure, and device repositioning before or after its detachment. To assess retrievability, four devices were deployed and intentionally embolized into the RA (n = 2) and LA (n = 2). The effectiveness of the device was evaluated by angiocardiography. EKG was recorded before and after PFO closure for 3 hr. From the 12 animals, nine were acute and three were followed; one for 6 weeks, one for 12 weeks, and one for 16 weeks.
  
  
  RESULTS
  Successful device implantation was achieved in all animals with no shunting of contrast media observed during follow-up in. One animal needed to have device repositioned for complete PFO occlusion because of suboptimal placement at the first attempt. The device was easily placed and retrieved before detachment in all nine animals in the acute study. None of the BDs spontaneously embolized during release or on follow-up. EKG did not demonstrate arrhythmias during or after treatment. Four intentionally embolized BDs were easily retrieved with an Amplatz goose neck snare. Macroscopic and histologic evaluation of the three long-term animals showed that devices were well incorporated in the atrial septum with complete shunt closure. The SIS showed progressive remodeling with the host cells. There was also progressive endothelization of the BD device.
  
  
  CONCLUSIONS
  The BD device deployment is feasible, safe, and effective. Long-term studies are needed to evaluate its long-term effectiveness.
authors.affiliation: Dotter Interventional Institute, Oregon Health Sciences University, Portland, Oregon 97201, USA. pavcnikd@ohsu.edu
authors.forename: Dusan
authors.initials: D
authors.lastname: Pavcnik
authors.forename: Kurt
authors.initials: K
authors.lastname: Takulve
authors.forename: Barry T
authors.initials: BT
authors.lastname: Uchida
authors.forename: Maja
authors.initials: M
authors.lastname: Pavcnik Arnol
authors.forename: William
authors.initials: W
authors.lastname: VanAlstine
authors.forename: Frederick
authors.initials: F
authors.lastname: Keller
authors.forename: Josef
authors.initials: J
authors.lastname: Rösch
mesh_terms: D000818:Animals; D006328:Cardiac Catheterization; D004867:Equipment Design; D005240:Feasibility Studies; D054092:Foramen Ovale, Patent / Q000628:therapy*; D055989:Septal Occluder Device; D013552:Swine