Measure of the amount of torque transmitted through the guidewire. Also known as Torque Response.
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.
- Proximal-to-distal rotational ratio
- 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
FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling
Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
FDA Guidance: Coronary and Carotid Embolic Protection Devices – Premarket Notification [510(k)] Submissions
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