Delivery System and GW Tip Stiffness Test
Delivery System and GW Tip Stiffness Test

 

 

 

 

 

 

 

 

Catheter Testing: Measured parameters

  • Trackability
  • Crossability
  • Pushability
  • Flexibility/Kink
  • Torquability
  • Rotational response
  • Torque to failure
  • Tip stiffness

 

Catheter Testing: Scope

  • Balloon catheter testing - functional performance
  • PTA, PTCA, coronary and peripheral stent systems testing - functional performance
  • Guidewires testing - functional performance
  • Endoscopic devices testing - functional performance
  • RF ablation catheters testing - functional performance
  • Any interventional delivery systems testing - functional performance

Associated catheter tests


  • Any performance tests related to implants (stent, stent-graft, heart valves)
  • Accelerate fatigue - Requirements for device pre-conditioning
  • Particulate matter evaluation - Requirements for device pre-conditioning

*IDTE 2000 Images Courtesy of Machine Solutions Inc

Catheter Testing: Test method description

PROTOMED uses the Interventional Device Testing Equipment (IDTE) 2000 to comparatively and quantitatively test and record the performance features of interventional devices. The IDTE equipment is PC controlled with numerous options for track configuration allowing for 2D and 3D testing. Testing results can be useful for regulatory submissions, pre-clinical trial testing, competitive product testing and product design. All IDTE Track tests are conducted using a tortuous model to simulate passage of the catheter through the vasculature. Standard or specific anatomical 3D models can be used to simulate device insertion, tracking and deployment.

Catheter Testing: Trackability

Uses the proximal load cell to measure the force to advance the device through a tortuous anatomy with or without the aid of a guiding accessory such as a guidewire, guide catheter, etc…

Catheter Testing: Pushability

Uses the proximal and distal load cell to measure the amount of force the distal tip of the device sees when a known force is being applied to the product on the proximal end.

Catheter Testing: Crossability

Uses the proximal load cell to measure the ability of the device to advance and withdraw, with no loss of function or damage to the tortuous anatomy, over a specific lesion site. The roller system and the camera allow determining the worst-case lesion that the stent can withstand without damage.

Catheter Testing: Flexibility/Kink

Uses the proximal load cell to measure the ability of the device to advance and withdraw, with no loss of function or damage to the tortuous anatomy, over a specific bend such as 90 degrees. The roller system and the camera allow determining the smallest radius of curvature that the stent can withstand without kinking.

Catheter Testing: Torquability

Uses the proximal and distal torque sensors to measure the amount of torque transmitted through the device by rotating the device at a more proximal location and fixing the distal end while the device is routed through tortuous anatomy.

Catheter Testing: Rotational response

Uses the proximal and distal rotation encoders to measure the amount of rotation transmitted through the device by rotating the device at a more proximal location and keeping free the distal end while the device is routed through tortuous anatomy.

Catheter Testing: Torque to failure

Uses the proximal and distal torque sensors to measure the amount of torque and the number of revolutions until device failure by rotating the device at a more proximal location and fixing the distal end while the device is routed through tortuous anatomy.