Occlutech PFO Occluder

Designed for safety and excellence

 The Flex II PFO occluder enables physicians to simplify implantations and achieve state-of-the-art results1 with a steep learning curve. Over 33,000 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
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

Language versions

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

Language versions

Info PFO

Literature

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.