Catheter Testing and Delivery System Testing
Catheters are used to deliver implantable devices or other therapies into the human body in a minimally invasive manner. These catheters may or may not include balloons which can be therapetic or used to deliver other cardiovascular devices to the target anatomy. 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 and balloon 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 and balloon designs.
Acute Particulate Matter Evaluation
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
Analysis and Computational Modeling
ViVitro Labs provides a large array of computational modeling tools, such as Finite Element Analysis (FEA), Computational Fluid Dynamics (CFD), Fluid-Structure Interaction (FSI) that can be used to assess the impact of anatomical and physiological boundary conditions on the design of a medical devices.Learn more
Balloon Cyclic Fatigue
Balloon Inflation Deflation Time
Balloon Rated Burst Pressure (RBP)
Burst Pressure Under Static Conditions
Catheter Compatibility Testing
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
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
Flexibility / Kink Resistance
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
Insertion / Retraction Force
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
Peak Tensile Force / Tensile Bond Strength
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
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.Learn more
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
Simulated Use Testing
Simulated Use Testing Under Pulsatile Flow
Simulated Use Testing with Backout Support
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
Torsional Bond Strength
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
Commonly tested devices include delivery catheters, guiding catheters, balloon catheters, Percutaneous Transluminal Angioplasty catheters (PTA) Percutaneous Transluminal Coronary Angioplasty catheters (PTCA), Central Venous Catheters (CVC), Peripherally Inserted Central Catheters (PICC), and dialysis catheters.
ISO 10555-1 Intravascular catheters —Sterile and single-use catheters —Part 1: General requirements.
ViVitro Labs provides catheter testing services such as Radio-detectability (or radiopacity) , surface examination, corrosion resistance, peak tensile force, Freedom from leakage (liquid leakage under pressure and leakage into hub assembly during aspiration), flowrate evaluation (flowrate through catheter), power injection (burst pressure under static conditions and Power injection test for flowrate and device pressure), side hole evaluation, distal tip evaluation, and designation of nominal size (outside diameter and nominal effective length).
ISO 10555-4 Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
ViVitro Labs provides catheter testing services such as radio-detectability (or radiopacity), designation of nominal size (diameter of inflated balloon, effective length of balloon at recommended pressure, diameter of the largest guidewire that can be used with the catheter), Balloon Rated Burst pressure (RBP), balloon fatigue; freedom from leakage and damage on inflation, balloon deflation time, balloon diameter to inflation pressure,
FDA-1608 FDA Guidance: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDA
ViVitro Labs provides catheter testing services such as dimensional verification (in accordance with ASTM2081), simulated use testing (balloon preparation, deployment and retraction in accordance with ASTM F2394), Balloon Rated Burst Pressure (RBP), balloon fatigue (repeat balloon inflations), balloon compliance (diameter vs. pressure), balloon inflation and deflation time, catheter bond strength, tip pull test, flexibility and kink test, torque strength, radiopacity, coating integrity, particulate evaluation, catheter body burst pressure, contrast media flow rate, balloon rated burst pressure (in stent), and balloon fatigue (repeat balloon inflations; in stent)
ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
ViVitro Labs provides stent testing services such as balloon burst pressure for non-compliant balloons, mean and rated burst pressure (RBP), balloon deflation time, balloon rated fatigue, balloon volume to burst for compliant balloons, dimensional verification of the endovascular system, dislodgement force (pre-mounted, balloon-expandable endovascular prosthesis), force to deploy for self-expanding endovascular prostheses, simulated use testing, tensile bond strength, torsional bond strength, haemostasis, visibility (radiopacity), Implant diameter to balloon inflation pressure, recoil,
FDA-1545 FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff
ViVitro Labs provides delivery system testing services such as dimensional verification, simulated use testing (delivery, deployment, and retraction), Balloon Rated Burst Pressure (RBP) , balloon fatigue (repeat balloon inflations), balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull test, flexibility and kink test, torque strength , coating integrity, and stent securement.