Circulatory Support Device Testing

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.

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

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

Durability testing is intended to determine the in-vitro lifetime, the anticipated failure modes, and  potential failure consequences (e.g. immediate total loss of  function or gradual degradation of  function).

ViVitro Labs can provide technical support and engineering solutions in the field of medical device testing. We provide flexible and responsive technical support services to help customers address project issues swiftly. Our clients can rapidly access engineers to discuss testing issues. Vivitro Labs provides a full range of engineering solutions through a true partnership with quality, integrity and confidentiality. These include customized test equipment solutions and customized test method development.

Using Digital Particle Image Velocimetry (DPIV),  pulsatile flow conditions in the immediate vicinity of the device can be analyzed to determine the viability of cardiovascular devices meeting regulatory standards. Triggers for disease (such as shear stresses and regions of stagnation) can be quantified with a high degree of accuracy. Advanced methods, including proper orthogonal decomposition, also capture the implicit fluid mechanical phenomenon of interest.

Hydrodynamic Performance Pulsatile Flow Testing – Forward flow and regurgitant performance of the device will be assessed under physiological pulsatile flow conditions. Key indicators of valve performance such as Effective Orifice Area (EOA) and regurgitant fraction (RF) are determined.

The pump performance will be evaluated against design specifications.

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.

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.

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

Characterize the performance of the device with or without pulsatile flow.

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.