Occlutech ASD Occluder​

Product features and benefits

  • The absence of the LA-hub provides flexibility.4
  • The absence of the LA-hub may facilitate neo-endothelialization.3, 5
  • Comparative study showed that the Occlutech ASD Occluder is associated with shorter procedure time (p= 0.166) and less radiation (p= 0.001).7
  • The ball-connector of the Occlutech ASD Occluder provides free rotation and force-free angulation up to 50 degrees and therefore facilitates implantation, alignment with the natural septal angle for operator confidence.6,7
  • The Occlutech ASD Occluder shows good procedural outcome and a low complication rate.10

Content references:

  1. Kenny_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. Catheter Cardiovasc Interv. 2018;1–6. DOI: 10.1002/ccd.27899
  2. Nir-David_ASD_IMAJ_Vol 19_September 2017_Comparing the Performance of Amplatzer and Occlutech Figulla Septal Occluders The peadiatric point of view. Doi:19: 557–561
  3. Haas_Catheterization and Cardiovascular Interventions (2016)_Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series, DOI: 10.1002/ccd.26497
  4. Tanabe_Journal of the American Heart Association (2021;10:e019282). Angioscopic Evaluation of Atrial Septal Defect Closure Device Neo-Endothelialization DOI: 10.1161/JAHA.120.019282 1
  5. Verified by pre-clinical studies, data on file (OCC 605-20 Final GLP Study Report)
  6. Leong_Cardiology in the Young (2022)_The-ceraflex-and-figulla-atrial-septal-occluders-early-and-intermediate-term-safety-and-efficacy-study_doi: 10.1017/S1047951121004728
  7. Aparisi_INTERVENTIONAL CARDIOLOGY_Cardiology Journal (2020), Vol. 27, No. 5, 524–532_Aparisi_Comparison of Figulla Flex® and Amplatzer™_DOI: 10.5603/CJ.a2020.0058 devices for atrial septal defect closure: A meta-analysis
  8. Verfied by data on file
  9. P17F03.030ml.02 ASD IFU data on file
  10. Leong et al., 20226 Early-onset complication rates in Amplatzer septal occluder, Ceraflex Septal occluder and Figulla atrial septal occluder were 3.83%, 5.56%, and 0%