Circulatory Support Devices

Circulatory support devices may be required for heart failure patients as a bridge to transplant or destination therapy. These devices may be Ventricular Assist Devices (VAD, LVAD, RVAD) or total artificial hearts (TAH).  Circulatory assistance may also be provided acutely for various reasons including additional flow requires during certain percutaneous procedures. These devices may include  Inter-aortic balloon pumps (IABP) or Ventricular Support Systems. 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 circulatory support 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 Circulatory support and circulatory assistance designs.

For catheter based systems see additional tests here.

For systems with integrated valves see additional tests here.

Courtesy of Abiomed

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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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Balloon Rated Burst Pressure (RBP)

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

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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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Durability Testing (Integrated Durability Assessment)

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).

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Engineering Support

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.

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Experimental Flow Field Assessment – Digital Particle Image Velocimetry (DPIV)

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.

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Pulsatile Flow Testing - Hydrodynamic Performance

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.

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Pump Performance Test

The pump performance will be evaluated against design specifications.

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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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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.

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Simulated Use Testing Under Pulsatile Flow

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

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System Characterization

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

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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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