Torqueability

Measure of the amount of torque transmitted through the guidewire. Also known as Torque Response.

Test Procedure

The proximal end of the device is rotated, and corresponding rotation of the unconstrained distal tip is measured. The device is routed through tortuous anatomy.

Measured Parameters

  • Proximal-to-distal rotational ratio
  • Temperature

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 25539-1:2017
    Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses

  • FDA-1658
    FDA Guidance: Coronary and Carotid Embolic Protection Devices – Premarket Notification [510(k)] Submissions

Related Tests

OLE0812


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:

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Victoria and Marseille labs accredited by A2LA.

Test Method Validation
The FDA and Notified Bodies around the world are requiring evidence of Test Method Validation. ViVitro Labs has invested significant resources to validate the most common test methods that are not ISO 17025 accredited. We continue to work closely with device manufacturers and share the burden with our clients to validate other specific test methods that are less in demand.

Timeliness
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Free Initial Consultations
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