Catheter Compatibility Testing

Accessories are used with the catheter. For examples guidewires, guiding catheters, and introducer sheaths are used with the catheter to show compatibility of lumens.

Test Procedure

The IDTE 1000 is used to monitor the tracking force applied on the test samples during simulated use.  The sample is advanced through the tortuous path according to the specific profile. Proximal forces, as well as the advancement distance, are recorded simultaneously throughout the anatomical model. The test fluid is circulated inside the anatomical model at a regulated at test temperature. The devices are inspected visually, and any damage is recorded.

Equipment

ViVitro uses the Interventional Device Testing Equipment (IDTE) 1000 to provide quantitative performance evaluation of interventional devices during simulated use testing. The device is advanced and retracted automatically by the roller system which removes bias due to operator interactions.  The IDTE proximal roller system measures advancement forces along the path and the auxillary load cells can be placed in various locations to measure distal forces on the device or resulting forces on interventional accessories.  The IDTE roller system can handle infinite length catheter and a continuous advancement of the device during testing. No repositioning of the head is necessary.  The IDTE equipment is PC controlled with numerous options for advancement profiles. Testing results can be used for regulatory submissions, competitive product evaluation and product development.

Measured Parameters

  • Maximum, minimum and average force
  • Location of maximum and minimum force
  • Temperature
  • Travel distance
  • Proximal Force
  • Distal Force

Scope

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

Service Levels

Applicable Standards

  • ISO 25539-2:2020
    Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

  • FDA-1608
    FDA Guidance: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDA

Related Tests

OLE1325


ViVitro Labs Advantages

Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:

Time to Market
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.

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