Occlutech UNI Occluder Designed for safety and excellence

in five sizes provides a wide range of choices.

force free angulation. 2, 3, 9

Available in five sizes, with equally sized discs from 17 mm to 40 mm, providing a wide range of choice.

Product features

  • New generation has optimized braiding pattern and less material at left atrial disc.
  • Two thin non-woven fabrics made of Polyethylenterephthalat (PET) patches help close the defect and provide growth of the endothelium over the Occluder after placement.5
  • The Occlutech UNI Occluder has conformable Nitinol braiding with a biocompatible titanium oxide surface.6
  • 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.2, 3, 9

Clinical benefits

  • Provides an option for the closure of multi-fenestrated ASDs which may require multiple devices.7, 8
  • Represents an alternative to a surgical approach to close multi-fenestrated ASDs.4

 Compatibility chart & ordering information

Product Instructions for Use

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Perfect alignment of the Occlutech UNI Occluder to the septum.

Occlutech UNI Occluder under fluoroscopy.

Content references:
  1. Miton, N. et al. Patent foramen ovale closure in children without cardiopathy: Child-PFO study. Archives of Cardiovascular Diseases 113, 513–524 (2020).
  2. 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.
  3. 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)
  4. Hijazi et al. ZM..Amplatzer investigators Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol. 2002;39:1836–1844. doi: 10.1016/S0735-1097(02)01862-4.
  5. Pedra, C.A.C., Pedra, S.F., Costa, R.N., Ribeiro, M.S., Nascimento, W., Campanhã, L.O.S., Santana, M.V.T., Jatene, I.B., Assef, J.E., Fontes, V.F., 2016. Mid-Term Outcomes after Percutaneous Closure of the Secundum Atrial Septal Defect with the Figulla-Occlutech Device. J Interv Cardiol 29, 208–215. https://doi.org/10.1111/joic.12284
  6. Kim, A. Y., Jung, S. Y., Chang, J. Y., Jung, J. W. & Choi, J. Y. Early to Mid-Term Follow-Up Outcomes of Percutaneous Closure of Atrial Septal Defects Using Recent Generation Devices: a Single-Center Experience. Korean Circ J 49, 326–335 (2018)
  7. Van Meerhaeghe, T., Droogmans, S., Hanon, S., Sonck, J., 2018. Platypnea-orthodeoxia syndrome: an unusual presentation of a complex disease. Acta Clin Belg 73, 224–228. https://doi.org/10.1080/17843286.2017.1356635
  8. Aubry, P., Brochet, E., Verdonk, C., Dilly, M.-P., Juliard, J.-M., 2015. 3-D transoesophageal echocardiography guidance in percutaneous closure of three distant atrial septal defects. European Heart Journal – Cardiovascular Imaging 16, 1045. https://doi.org/10.1093/ehjci/jev114
  9. Data on file
Not approved or available for sale in the United States. Product(s) may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Occlutech representative if you have questions about the availability of Occlutech products in your area.

The Occlutech UNI Occluder has not received FDA Premarket Approval, or been licensed by Health Canada.