Occlutech PFO Occluder

​Designed for safety and excellence

Product features

  • The Occlutech PFO Occluder has conformable Nitinol braiding with a biocompatible titanium oxide surface.15
  • Optimized braiding: no hub on the left atrial disc to facilitate endothelization.21, 22
  • Biocompatible Polyethylenterephthalat (PET) patch allows immediate verification of the occlusion effect by ultrasound and X-ray.
  • The ball connection allows up to a 50 degree angle which is intended to reduce tension on the septum, and allow septal alignment prior to release.13, 14, 22

Clinical benefits

  • PFO closure using the Occlutech PFO Occluder reduces recurrent stroke ascribed to PFO.1-3 This reduction was proven successfully in retrospective and prospective clinical trials.17-19
  • Mean procedure time: less than 30 minutes with reduced (P = 0.47) mean fluoroscopic time less than 4.4 mins.1
  • The Occlutech PFO Occluder shows procedural success rate of 99% with efficient closure in 95.5% after six months.1, 20

Content references:

  1. Trabattoni, D. et al. AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure. EuroIntervention 12, 2092–2099 (2017)
  2. Snijder, R et al. Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient-years of follow up. Catheterization and Cardiovascular Interventions 93, (2018)
  3. Snijder et al. Microtransesophageal Echocardiographic Guidance during Percutaneous Interatrial Septal Closure without General Anaesthesia. J Interv Cardiol 2020, 1462140 (2020)
  4. Honek J, et al. Patent Foramen Ovale Closure Is Effective in Divers: Long-Term Results From the DIVE PFO Registry. J Am Coll Cardiol 76, 1149–1150 (2020)
  5. Ates Long-term follow-up outcomes in a real-world study cohort after percutaneous patent foramen ovale closure. (2010)
  6. Aral and Mullen. The Flatstent versus the conventional umbrella devices in the percutaneous closure of patent foramen ovale. Catheter Cardiovasc Interv 85, 1058–1065 (2015)
  7. Davies et al. Multidisciplinary Assessment in Optimising Results of Percutaneous Patent Foramen Ovale Closure. Heart Lung Circ 26, 246–250
  8. Hildick-Smith, D. et al. Occlutech percutaneous patent foramen ovale closure: Safety and efficacy registry (OPPOSE). Int J Cardiol 245, 99–104 (2017)
  9. Neuser, J. et al. Mid-term results of interventional closure of patent foramen ovale with the Occlutech Figulla® Flex II Occluder. BMC Cardiovasc Disord 16, 217 (2016)
  10. Scalise et al. Long-Term contrast Echocardiography and clinical Follow-up after percutaneous closure of PFO using two different ASD devices (2016)
  11. Wittczak et al. Transcatheter closure of patent foramen ovale in patients with cryptogenic stroke: impact on arrhythmia in 3 months follow-up. Folia Cardiologica 16 (2021)
  12. Willits et al. Patent foramen ovale closure: A prospective UK registry linked to hospital episode statistics. PLoS One 17, e0271117 (2022)
  13. Leong, M. C., Karyostyko, B., Ramli, M. N. H., Tan, J. W. Y. & Alwi, M. The Ceraflex and Figulla atrial septal occluders: early and intermediate-term safety and efficacy study. Cardiol Young 1–7 (2022) doi:10.1017/S1047951121004728.
  14. Kenny, D. et al. A randomized, controlled, multi-center trial of the efficacy and safety of the Occlutech Figulla Flex-II Occluder compared to the Amplatzer Septal Occluder for transcatheter closure of secundum atrial septal defects. Catheterization and Cardiovascular Interventions 93, (2018)
  15. Castleman et al (1997). Biocompatibility of Nitinol Alloy as an Implant material. Journal of Biomedical Materials Research. 97 6;10:695
  16. Electrochemical Characterization of Nitonol Occluder, Natural and Medical Sciences Institute at the University of Tubingen. mNl<0.14ug (cm*d)
  17. Saver, J. L. et al. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. New England Journal of Medicine 377, 1022–1032 (2017)
  18. Søndergaard, L. et al. Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke. N Engl J Med 377, 1033–1042 (2017)
  19. Mas, J. L. et al. Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke. New England Journal of Medicine 377, 1011–1021 (2017)
  20.  PROOF_CSR_02Feb2023_final (Internal document)
  21. Tanabe, Y. et al. Angioscopic Evaluation of Atrial Septal Defect Closure Device Neo- Endothelialization. J Am Heart Assoc 10, e019282 (2021).
  22. Data on file