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 LabelingISO 25539-1:2017
Cardiovascular implants — Endovascular devices — Part 1: Endovascular prosthesesFDA-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:
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.
ISO 17025 Accredited
For studies used for regulatory approval this is a must. Victoria and Marseille labs accredited by A2LA.
Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.
Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.