Catheters and Delivery Systems

Catheters are used to deliver implantable devices or other therapies into the human body in a minimally invasive manner.  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 catheter testing services in accordance with ISO standards, ASTM Standards,  FDA guidance documents, and the latest peer reviewed research.

ViVitro Labs is a leader in providing standardized as well as customized test methods for cutting edge or novel catheter designs.

Courtesy of Alvimedica

<

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.

Learn more
<

Air Leakage During Aspiration - Catheter Hub Assembly

Catheters are connected to a partially filled syringe, a negative pressure is applied by pulling on the syringe plunger, visual inspection is performed to detect any bubbles forming in the syringe.

Learn more
<

Balloon Compliance

Balloon pressure and corresponding balloon diameter is verified for the full range of recommended inflation diameters.

Learn more
<

Balloon Cyclic Fatigue

Balloons must withstand multiple inflations during clinical use to avoid inducing device failure or vessel damage.

Learn more
<

Balloon Inflation Deflation Time

The time to inflate and deflate a balloon catheter to a predefined target pressure is measured.

Learn more
<

Balloon Rated Burst Pressure (RBP)

Determination of maximum pressure a balloon can withstand clinically before bursting also known as the rated burst pressure (RBP).

Learn more
<

Burst Pressure Under Static Conditions

The pressure at which the entire catheter assembly bursts.

Learn more
<

Catheter Compatibility

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

Learn more
<

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.

Learn more
<

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.

Learn more
<

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.

Learn more
IDTE 1000
<

Dimensional Attributes

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

Learn more
Smartscope
<

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.

Learn more
<

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.

Learn more
HYDROPHILIC COATING FRICTION TEST 2 - PINCH TEST
<

Insertion / Retraction Force

Uses both the proximal and distal load cell to measure the amount of force applied on the device and a specific accessory during retraction.

Learn more
IDTE 1000
<

Kink Resistance Under Flow – Short and Long Term

Determine the kink resistance of a single lumen catheter or medical tubing for short term (< 1h) or long term (> 1h) use.  Kink is defined when the bending causes a decrease in flow by more than 50 %.

Learn more
<

Liquid Leakage Under Pressure - Catheter Hub Assembly

Catheter hubs are checked for leaks by applying constant pressure.

Learn more
<

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.

Learn more
<

Profile Effect / Flaring

Ensure the distal tip of crimped stent remains in contact with the balloon at all times, while navigating through a tortuous path. The degree of flaring of the stent away from the balloon is measured.

Learn more
<

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.

Learn more
<

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 test sample and a user-defined standard with or without the use of a body mimic.

Learn more
<

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.

Learn more
<

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.

Learn more
<

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.

Learn more
IDTE 1000
<

Simulated Use Testing Under Pulsatile Flow

Devices can be subjected to various physiological pulsatile flows and pressures.

Learn more
<

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.

Learn more
IDTE 1000
<

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.

Learn more
<

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.

Learn more
<

Torqueability

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

Learn more
<

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.

Learn more
<

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.

Learn more
IDTE 1000
<

Withdrawbility

Involves retracting or re-sheathing the device as part of simulated use testing.

Learn more
IDTE 1000

Join over 5000 cardiovascular device professionals who receive our testing and engineering insights and tips every month.