The Interventional Device Testing Equipment (IDTE) from MSI comparatively and quantitatively tests and records the performance features of interventional devices including: catheters, guidewires, stent delivery systems, colonoscopes, endoscopes and scope tools. The IDTE equipment is PC controlled with numerous options for track configuration allowing for two and three dimensional testing. Testing results can be useful for regulatory submissions, pre-clinical trial testing, competitive product testing and product design.
The IDTE was designed with several international testing standards in mind. These include: ASTM F2394-04 for preconditioning of the stent on the deployment system prior to retention testing, ISO Standard 25539-1:2003(E) Titled "Cardiovascular Implants - Endovascular Devices” and ISO/TS 15539:2000(E) Titled "Cardiovascular Implants - Endovascular Prostheses”.
Standard Testing Protocols:
• Track force - Uses the Proximal load cell to measure the force to advance a device such as a catheter, delivery system, stent system, endoprosthesis system, etc, through a tortuous anatomy with or without the aid of a guiding accessory such as a guidewire, guide catheter, guide sheath, microcatheter, etc.
• Withdraw force - Uses the Proximal load cell to measure the force to retract a device such as a catheter, delivery system, stent system, endoprosthesis system, etc, through a tortuous anatomy with or without the aid of a guiding accessory such as a guidewire, guide catheter, guide sheath, microcatheter, etc. after accessing the intended anatomy site.
• Push efficiency - Uses the proximal and distal load cell to measure the amount of force the distal tip of the device such as a catheter, delivery system, stent system, endoprosthesis system, etc sees when a known force is being applied to the product on the proximal end.
• Insertion Force Measurement - Uses the proximal load cell to measures the force used to advance through the introducer sheath.
• Guidewire Movement - Uses the proximal load cell to measure the force needed to advance a guidewire though a catheter, guide catheter or other interventional device.
• Flexibility - Uses the proximal load cell to measure the ability of a device such as a catheter, delivery system, stent system, endoprosthesis system, etc. to advance and withdraw, with no loss of function or damage to the tortuous anatomy, over a specific bend such as 90 degrees.
• Crossability - Uses the Proximal load cell to measure the ability of a device such as a catheter, delivery system, stent system, endoprosthesis system, etc. to cross (traverse) a given feature of a tortuous anatomy such as a lesion, stenosis, stent, etc. in the delivery path with the portion of the device required for the intended therapy.
• Torquability - Uses the proximal and distal torque sensors to measure the amount of torque transmitted through the device such as a catheter, delivery system, stent system, endoprosthesis system, 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 torque sensor and the distal rotations out fixture to measure the ability to cause axial rotation of the distal end of a device such as a catheter, delivery system, stent system, endoprosthesis system, etc by rotating the device at a more proximal location when the device is routed through a tortuous anatomy.
• Torque to Failure - Uses the proximal torque sensor and distal torque or distal tension to measure the proximal torque and distal torque that causes failure in a device (constant length test) or to measure the proximal torque that causes failure in a device by applying constant tension (constant tension test).
