Occlutech PFO Occluder
Designed for safety
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
- 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
- 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
The Flex II PFO has not received FDA Premarket Approval.
Movie showing in a general way the mechanism of a PFO related cryptogenic stroke
Movie showing in a general way how an Occlutech PFO Occluder is implanted
- 2017_Hildick-Smith Occlutech percutaneous patent foramen ovale closure: Safety and efficacy registry (OPPOSE) UK.
- 2018_Snijder PFO closure in 250 patients and 1300 patient years FU using the Occlutech Figulla device.
- 2017_PFO Trabattoni Italian Comparative II Amplatzer vs Figulla occluder.
- Castleman LS et. al. Biocompatibility of Nitinol Alloy as an Implant Material. Journal of Biomedical Materials Research/ 97 6;10:695.
- Electrochemical Characterization of Nitinol Occluder, Natural and Medical Sciences Institute at the University of Tubingen, mNl<0,014 µg/(cm*d).
- 2017_Mas_Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke.
- 2017_Trabattoni_AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure.
- 2013_Zuh_Oxidation of Nitinol and Its Effect on Corrosion Resistance.