Guidewire Testing - Functional PerformanceGuidewire Testing

 

 

 

 

Guidewire Testing: Measured parameters

  • Tensile strength
  • Torque strength
  • Trackability
  • Pushability
  • Flexibility/Kink
  • Torquability
  • Tip stiffness
  • Coating integrity
  • Crossability
  • Catheter compatibility
  • Rotational response
  • Torque to failure

Guidewire Testing : Scope

  • Coronary Guidewire functional performance
  • Cerebrovascular Guidewire functional performance
  • Peripheral Guidewire functional performance

Associated tests


  • Particulate matter evaluation
  • Radiopacity
  • Flex/kink
  • Corrosion
  • All requirements for device pre-conditioning

*IDTE 2000 Images Courtesy of Machine Solutions Inc

Test method description

PROTOMED uses the Interventional Device Testing Equipment (IDTE) 2000 to comparatively and quantitatively tests and records 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.

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…

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.

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

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

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.

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.

Torque to failure

Uses the proximal and distal torque sensors to measure the amount of torque and the number of revolution 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.