Occlutech PFO Occluder

Designed for safety
and excellence

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Product Instructions for Use

The Flex II PFO occluder enables physicians to simplify implantations and achieve state-of-the-art results1 with a steep learning curve. Over 36,000 PFO occluders have been delivered to over 70 countries around the world, with track records for performance and safety.2

Product features

  • The unique ball-connection between pusher and Occluder safely locks it, while it freely follows the anatomy. Once in place it is easy and quick to deliver.3
  • Handknitted biocompatible PET-patch allows immediate verification of the occlusion effect by ultrasound and X-ray.
  • Titanium oxide covered Nitinol shows the best values of biocompatibility4 and minimized Nickel release.5
  • Optimized braiding: No hub and reduced material on the left arterial disc guarantees better ingrowth.6

 

Clinical benefits

  • Superior periprocedural outcome and midterm results for PFO restshunt rate.3
  • Excellent results in studies with recurrent stroke endpoint. No strokes in 5.3 years follow up.7
  • Mean procedure time: Less than 30 minutes with reduced fluoroscopic time.8
pfo

The Flex II PFO has not received FDA Premarket Approval.

PFO
PFO material and design characteristics

TEE cross section of an optimally implanted
PFO Occluder.

The hubless distal disc in 3-D TEE projection.

The Flex II in X-ray view.

 

Movie showing in a general way the mechanism of a PFO related cryptogenic stroke

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Movie showing in a general way how an Occlutech PFO Occluder is implanted

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pfo product specifications
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Info PFO

Literature

Publications
Content references:
  1. 2017_Hildick-Smith Occlutech percutaneous patent foramen ovale closure: Safety and efficacy registry (OPPOSE) UK.
  2. 2018_Snijder PFO closure in 250 patients and 1300 patient years FU using the Occlutech Figulla device.
  3. 2017_PFO Trabattoni Italian Comparative II Amplatzer vs Figulla occluder.
  4. Castleman LS et. al. Biocompatibility of Nitinol Alloy as an Implant Material. Journal of Biomedical Materials Research/ 97 6;10:695.
  5. Electrochemical Characterization of Nitinol Occluder, Natural and Medical Sciences Institute at the University of Tubingen, mNl<0,014 µg/(cm*d).
  6. PFO_18/19_PD_vers03.
  7. 2017_Mas_Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke.
  8. 2017_Trabattoni_AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure.
  9. 2013_Zuh_Oxidation of Nitinol and Its Effect on Corrosion Resistance.