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
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.

Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.