Pushability

Pushability uses the proximal and distal load cell to measure the amount of force the distal tip of the guidewire sees when a known force is being applied to the product on the proximal end.

This corresponds with the force applied by a physician when advancing a catheter to the therapeutic location.

Test Procedure

A distal load cell is placed at the end of the tortuous path. The device is pushed through the tortuous path according to the specific profile. Proximal and distal forces, as well as the advancement distance, are recorded simultaneously. Pushability is measured from the ratio distal force / proximal force. The camera can be used to record tip behavior and possible buckling or kinking of the catheter. Proximal and distal forces, as well as the advancement distance, are recorded simultaneously. The test fluid is circulated inside the anatomical model at a regulated at test temperature ±2°C. The devices are inspected visually, and any damage is recorded.

Equipment

ViVitro uses the Interventional Device Testing Equipment (IDTE) 1000 to provide quantitative performance evaluation of interventional devices during simulated use testing. This test is conducted by advancing a device in a pre-defined anatomical vascular model to simulate the passage of devices during interventional procedures. Standard or specific anatomical 2D and 3D models can be used to simulate device insertion, tracking, deployment and retrieval.

The device is advanced and retracted automatically by the roller system which removes bias due to operator interactions. The IDTE proximal roller system measures advancement forces along the path and the auxillary load cells can be placed in various locations to measure distal forces on the device or resulting forces on interventional accessories. The IDTE roller system can handle infinite length catheter and a continuous advancement of the device during testing. No repositioning of the head is necessary. The IDTE equipment is PC controlled with numerous options for advancement profiles. Testing results can be used for regulatory submissions, competitive product evaluation and product development.

Measured Parameters

Maximum, minimum and average force
Location of maximum and minimum force
Temperature
Travel distance
Proximal Force
Distal Force

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

ISO 25539-2:2020
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
FDA-16007
FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling

Related Tests

OLE0811

Push Track Testing on IDTE 1000

Pushability testing - IDTE 1000 distal load cell

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.