Occluder testing - Cardiovascular Implants

Questmed GmbH is a Test Laboratory for Occluder and Closure Device Testing of Cardiovascular Implants. We are testing Cardiovascular Implants like Occluder for fatigue and durability and other mechanical loads in accordance with ISO 22679, ASTM F3211, ISO 25539-1, ISO 25539-2 and ISO 25539-3.
For fatigue and durability testing with axial and hydrodynamic loads we use our accredited test procedure.
We are the first and only test lab with an accreditation for Occluder - Durability under axial and hydrodynamic load testing.
We have experience since 2011 for testing all kinds of occluders, for instance
  • patent foramen ovale occluder (PFO),
  • atrial septal occluder (ASD),
  • patent ductus arteriosus occluder (PDA),
  • ventricular septal occluder (VSD),
  • paravalvular leak occluder (PVL),
  • left atrial appendage occluder (LAA),
  • atrial flow regulator (AFR),
  • cardiac patches or strips.

Differential hydrodynamic pressure test

The test should run according ISO 22679 Annex H.3 "Durability of the occluder implant".
Fatigue and durability tests run with 1.2 Hz up to 90 Hz at 37 °C tempered 0.9 % saline solution.
Occluder hydrodynamic test principle
Our multidevice cardiac implant test systems for Occluder are available for 1 to 30 Samples.
Occluder are mounted using flexible adapter up to 60 mm in height and 60 mm in diameter.

Occluder hydrodynamic test setup
High cycle fatigue and durability testing demonstrates the Occluder´s ability to withstand physiological stresses during long term implantation.
We perform pulsatile fatigue and durability testing for 10 million up to 600 million cycles.
Our test systems provides highspeed pressure tests with differential hydrodynamic pressures to the occluder with highspeed data recording to test the performance of Occluders using the Questmed OTV test system.
Pulsatile flows simulate the intended deployment location for Occluder and Closure Devices.
Steady flow will also be performed to better understand the fundamental operation of devices.
Tests include:
  • Fatigue testing
  • Durability testing
  • Short-term and long-term pressurization
  • Interim visual inspections without removing the test samples
  • Stroboscope Visual Inspection
  • Metal ion analysis like nickel and titanium

Differential pressure pulsation for fatigue and durability testing sorted by type of Occluders

  • Type - Differential Pressure pulsation (ISO 22679 Annex O)
  • PFO - diff 14 mmHg
  • ASD - diff 14 mmHg
  • PDA - diff 110 mmHg
  • VSD - diff 110 mmHg
  • PVL - diff 119 mmHg
  • LAA - diff 27 mmHg (persistent atrial fibrillation)
  • LAA - diff 18 mmHg (contraindication atrial fibrillation)
  • AFR - diff 30 mmHg
  • AAA - diff 20 mmHg

Axial fatigue and durability testing

Axial tests run with 10 Hz up to 90 Hz in 37 °C tempered 0.9 % saline ringer's solution.
Our multidevice cardiac implant test system for Occluders is available for 12 Samples.

Occluder axial test principle

Biocompatibility - Nickel ion release

We perform nickel ion release test according ASTM F3306 in accordance with Chapter III. C. 1. Biocompatibility - Nickel ion release FDA Guidance Document 1545, Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems Guidance for Industry and Food and Drug Administration Staff Document issued on: August 18, 2015

Questmed Occluder Skills / Expertise

Download a presentation of Questmed Occluder Testing with Skills / Expertise, presented at DIN Workinggroup Session 2021-06-18 - NA 027-05-06 AA "Herz- und Gef├Ą├čimplantate".

Download "Questmed Occluder Skills / Expertise" as PDF.