Other Cardiovascular Devices

Many new classes of  devices do not have standards like more established technologies.  We excel at breaking down a complex device and pathophysiology into a justifiably simplified bench top test. Each will have well defined:

  • Operating conditions [eg. inlet pressure, outlet pressure, internal chamber pressure (if applicable), inflow, outflow, relevant mock heart chamber pressures, cardiac output, and systolic duration]
  • Test fluid properties (Chemical composition, temperature, viscosity, density, pH)
  • A priori defined acceptance criteria such as acceptable pressure drops, retrograde flow, etc.

Our test plans and reports are designed around approval bodies, thoroughly researched, and justified to ensure they are regulatory appropriate. Contact us today to discuss your cardiovascular testing needs.

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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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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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Ex-Vivo Beating Heart

Our ex-vivo beating heart simulator is used to test transcatheter devices when realistic anatomy is required.

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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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Literature Review

ViVitro can perform a literature review to support the development of a specific device.  This can used to build a rational as requested by the client.

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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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Scanning Electron Microscopy (SEM) and Optical Inspection

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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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