Occlutech PLD Occluder​ Designed for safety and excellence

first European device launched specifically for the closure of Paravalvular leaks, treating patients since 2014.

the design of the devices, choice of square or rectangular option, with a Twist or Waist, allows alignment over the leak which aids in achieving closure of Paravalvular leaks.

force free angulation during release. 7, 8, 9

Paravalvular leak closure
The Occlutech PLD Occluder is a device specifically designed for closing paravalvular leaks and offers a range of features. The device can be delivered from various routes (Antegrade transeptal puncture and Retrograde technique) using delivery catheters.

Product features

  • Two gold markers facilitate optimal positioning.
  • Repositionable and fully retrievable.
  • Double disc device made from nitinol braided wires with two Polyethylenterephthalat (PET) patches – one in each disc.
  • Available with different design options for different Paravalvular leak morphologies.

Clinical benefits

  • Transcatheter Paravalvular leak closure offers a minimally invasive alternative for patients with high surgical risk.1
  • High success rate in achieving complete closure.2-6

Material and design characteristics

 Compatibility chart & ordering information

Product Instructions for Use

Looking for the user instructions to our implants and accessories?

Live Cases

Watch live cases from implantations and placements of our occluders.

Publications

Get the latest documentation
on our devices.

Typical half-moon shaped paravalvular leak.

Paravalvular leak closed with Occlutech PLD (61PLD10W).

Content references:
  1. Vahanian et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632 doi: 10.1093/eurheartj/ehab395
  2. Onorato et al,. Safety, Efficacy and Long-Term Outcomes of Patients Treated with the Occlutech Paravalvular Leak Device for Significant Paravalvular Regurgitation. Journal of Clinical Medicine. 2022, 11, 1978. https://doi.org/10.339 /jcm11071978.
  3. Zorinas et al,. “Retrospective analysis of single-center early and midterm results of transapical catheter based mitral paravalvular leak closure with a purpose-specific
    device,” Adv. Interv. Cardiol., vol. 14, no. 2, pp. 167–175, 2018, doi: 10.5114/aic.2018.76408
  4. Aguero et al et al,. Severe hemolysis after transapical closure of mitral perivalvular leak requiring transeptal reintervention. Revista Argentina de Cardioangiología Intervencionista 2020;11(2):73-76. https://doi.org/10.30567/RACI/202002/0073-0076 (Case Report)
  5. Balanescu et al,. EchoNavigator® technology facilitates transapical mitral paravalvular leak closure: a case report,” Eur. Heart J. – Case Rep., vol. 5, no. 6, p. ytab190, May 2021, doi:10.1093/ehjcr/ytab190
  6. Raczkiewicz et al,. First report of percutaneous closure of anterior mitral leaflet perforation using a paravalvular leak device (PLD),” Adv. Interv. Cardiol., vol. 3, pp. 274–275, 2016, doi: 10.5114/aic.2016.61653. (Case Report).
  7. 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/S104795112100472
  8. 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)
  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 PLD Occluder has not received FDA Premarket Approval, or been licensed by Health Canada.