Torque Strength

Intravascular/endovascular devices may be subjected to torsional forces during use. Inability to withstand torsional forces that are typical of clinical use could lead to device failure or vessel damage.

Test Procedure

The sample is tracked through a tortuous path defined in the test protocol. The distal tip of the device is not free to rotate (blocked by a jaw) and rotations are applied at the proximal end of the device (fixed on a rotation torquer) until failure. The distal tip of the sample is filmed during the test. The number of rotations to failure of the device and the failure mode are reported. A snapshot of the device before the failure and/or the number of rotations before the first twist (if a twist happens before the failure) can be recorded if requested by the sponsor.

Measured Parameters

Number of turns to failure

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-1545
FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff
FDA-1608
FDA Guidance: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDA
FDA-16007
FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling
FDA-16013
FDA Guidance: Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions
FDA-1658
FDA Guidance: Coronary and Carotid Embolic Protection Devices – Premarket Notification [510(k)] Submissions

Related Tests

OLE2501

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

Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.

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