Guidewire Testing Services

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.

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

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.

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.

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.

Test samples coupons or the entire length of a catheter are chosen so that each tubular portion, each junction between hub or connector and tubing, and each junction between tubular portions is tested. A tensile force is applied to each test piece until the tubing breaks or the junction separates.

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

Medical device may be subjected to tight angulations in tortuous vasculature during use. Inability to withstand flexural forces that are typical of clinical use could lead to device failure or vessel damage.  The ability of a delivery system or a catheter to bend in order to accommodate the predetermined clinically relevant radius or angles is critical during vascular access. The ability of a stent like structure to bend without lumen narrowing plays a critical role in maintaining stent patency

The guidewire is wrapped around a predefined cylindrical fixture.  Once removed the guidewire is examined for visible signs of fracture

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.

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.

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.

A guidewire can be subjected to flexing or bending during clinical use. The guidewire shall not be damaged and device characteristics shouldn’t be changed to guarantee the intervention success.

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.

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

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.

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

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.

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

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.

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

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.

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.

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