Guidewire Testing Services

Guidewires facilitate catheter placement and exchange by navigating through vessels to the therapy location. Guidewires can be intended for use in the coronary vasculature, peripheral, vasculature, and neurovasculature   A number of methods are used to ensure these devices demonstrate safety, efficacy, and quality, while performing according to their intended use and labeling. We offer comprehensive guidewire testing services in accordance with ISO standards, ASTM Standards,  FDA guidance documents, and the latest peer reviewed research.

 

Guidewire Testing Services

Courtesy of Abbott – GuideRight™ guide wire

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Acute Particulate Matter Evaluation

An in-line continuous particulate counting system is used to assess the number and sizes of  particles generated during simulated use in real-time inside an anatomical model.

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Catheter Compatibility Testing

Accessories are used with the catheter. For examples guidewires, guiding catheters, and introducer sheaths are used with the catheter to show compatibility of lumens.

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Coating Integrity Optical Inspection

A Scanning Electron Microscope (SEM) and/or an optical microscope with proper magnification is used to inspect the surface defects and coating integrity of the device before and after testing. Coating anomalies, defects or artefacts are located and documented.

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Corrosion - Immersion Test

The catheter is immersed in a physiological saline solution for 5 hours then in boiling distilled or dionized water for 30 min. Samples are kept at 37°C for 48 hours before cooling down to room temperature. Test samples are visually inspected for traces of corrosion with an optical microscope in comparison to reference samples.

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Crossability

Uses the proximal load cell to measure the ability of the device to advance and withdraw, with no loss of function or damage to the tortuous anatomy, over a specific lesion site. The roller system and the camera allow determining the worst-case lesion that the stent can withstand without damage.

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Trackability
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Dimensional Attributes

A contactless optical gauging machine is used to measure dimensional attributes of the device.

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Smartscope
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Flexibility / Kink Resistance

Ability of the device to bend in order to accommodate the predetermined clinically relevant radius or angle it will be required to negotiate during access and delivery.

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Flexing

The portion of the guidewire under test is subjected to repeated reverse bending and straightening for up to 20 times, then examined for damage and flaking of the coating.

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Fracture of Guidewires

The guidewire is wound around a cylindrical former, then unwound and examined for fractures.

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Hydrophilic Coating Friction Test - Lubricity/Pinch Test

The purpose of this test is to assess the lubricity and the durability of hydrophilic coatings (on balloons, catheters etc). The most common test used for finding friction at a surface is a pinch test, where test samples are pinched between two plates (pads) with a known amount of force or a defined distance, while using a motor to pull and/or push the test article through the plates. The force it takes to pull and/or push the device through can be measured. Passing the device through the pinch test multiple times will eventually cause the coating to fail and friction readings to increase.

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HYDROPHILIC COATING FRICTION TEST 2 - PINCH TEST
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Peak Tensile Force / Tensile Bond Strength

Tensile test (uniaxial) to determine the bond strength at locations where adhesives, thermal fusion, or other joining methods are used for bonding components of the delivery system.

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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.

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Pushability
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Radiopacity

Test specimens are exposed to X-Ray levels necessary for the imaging system and the product or material. Digital analysis method is used to produce the images in accordance with the equipment manufacturer’s instructions. Radiopacity of the device is determined by qualitatively comparing X-ray image(s) of a test sample and a user-defined standard with or without the use of a body mimic.

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Rotational Response

A customer-defined number of revolutions is applied to the proximal end of a device with a customer defined step. At each step, the corresponding rotation at the distal end is measured by direct reading on the distal measurement system and then recorded. The tests can be performed in straight path or in a predefined arterial model.

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Simulated Use Pre-conditioning

Before conducting other evaluations, test samples should undergo all the steps a finished device would go through before being implanted in the patient.

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Simulated Use Testing

Uses the roller system and the camera to qualitatively evaluate the performance of the device using a tortuous path that simulates the intended use conditions.

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Trackability
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Simulated Use Testing with Backout Support

A catheter is deployed over a guidewire. The catheter is removed and guidewire must be left in place. Special case of Simulated use testing.

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Trackability
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Three-Point Bending

The rigidity of catheter, stent, or endovascular device is measured using a three point deflection method. The sample rests perpendicular to two lower static supports, with an applied deflection site centered between them. A displacement is applied at a fixed rate while measuring the resultant force. The test stops when the displacement reaches 0.2 x span length.

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Tip Flexibility / Tip Stiffness

Determine the flexibility of the guidewire tip by measuring the buckling deformation force.

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Trackability
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Torque Strength

Rotate the proximal end of the catheter while the distal end is fixed and routed through a tortuous anatomy. The number of turns to failure is recorded.

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Torqueability

Measure of the amount of torque transmitted through the guidewire. Also known as Torque Response.

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Torsional Bond Strength

The purpose of this test is to determine the torque required to cause failure of the joints and/or fixed connections in the catheter system.

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Trackability

Trackability uses the proximal load cell to measure the force to advance the device through a tortuous anatomy with or without the aid of a guiding accessory such as a guidewire, guide catheter, etc.

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Trackability
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Withdrawbility

Withdrawbility involves retracting or re-sheathing the medical device as part of simulated use testing to determine the ability to withdraw.

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Trackability
ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires.

ViVitro Labs provides guidewire testing services such as guidance on size designation, safety wires, fracture, flexing, peak tensile force, and  corrosion.

FDA Guidance (document number 16007, Docket Number:FDA-2018-D-1775) Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling.

ViVitro Labs provides guidewire testing services such as predicate comparison and non-clinical bench testing including pre-conditioning, simulated use (and simulated use models), dimensional verification, tensile strength, tip pull, torque strength, torquability, coating integrity, particulate evaluation, lubricity, corrosion resistance, kink resistance, tip flexibility, and radiopacity.

Other standards such as ISO 25539-2:2020 give guidance on catheter compatibility and ViVitro Labs is a leader in providing customized test methods for cutting edge or novel guidewire designs.

While guidewires may seem simplistic to the untrained eye, in reality they are highly complex composite devices which contain multiple interacting elements. There may be a core wire which provides stiffness to the system. The coil of a guidewire is helically wound wire (typically around the core). The guidewire may contain a safety wire which is an additional wire to minimize the possibility of tip detachment. The guidewire may have a formed and shaped tip to allow for easier navigation through tortuous anatomy. Guidewires may have a hydrophilic coating to improve lubricity. There continues to be many technological advancements in this space and ViVitro is an industry leader in developing guidewire testing services for these novel devices.

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