Withdrawbility

Withdrawbility involves retracting or re-sheathing the medical device as part of simulated use testing to determine the ability to withdraw.

Uses the Proximal load cell to measure the force to retract or re-sheath the device from a tortuous anatomy with or without the aid of a guiding accessory such as a guidewire, guide catheter, etc.

Test Procedure

The system is retracted back to the starting point through the track model. During retraction, the IDTE 1000 proximal load cell is used to monitor the force applied at the proximal end of the device. At the same time, an encoder, attached to the proximal load cell, is used to monitor the travelled distance.  Proximal forces, as well as the advancement distance, are recorded simultaneously. The test fluid is circulated inside the anatomical model at a regulated at test temperature ±2°C. 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. This test is conducted by advancing a device in a pre-defined anatomical vascular model to simulate the passage of devices during interventional procedures. Standard or specific anatomical 2D and 3D models can be used to simulate device insertion, tracking, deployment and retrieval.

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

  • PTA, PTCA, coronary and peripheral stent delivery systems – functional performance during simulated use
  • TAVI and TMVR delivery systems – functional performance during simulated use
  • Thrombectomy devices — functional performance during simulated use
  • Guidewires testing – functional performance during simulated use
  • Endoscopic devices – functional performance during simulated use
  • RF ablation catheters testing – functional performance during simulated use
  • Any interventional delivery systems – functional performance during simulated use

Service Levels

Applicable Standards

  • FDA-16007
    FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling

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

Related Tests

OLE0813

Trackability

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