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.

<

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
<

Determination of longitudinal tensile strength (endovascular device)

Test samples coupons or the entire length of a catheter are chosen so that each tubular portion, each junction between hub or connector and tubing, and each junction between tubular portions is tested. A tensile force is applied to each test piece until the tubing breaks or the junction separates.

Learn more
<

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.

Learn more
<

Ex-Vivo Beating Heart

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

Learn more
<

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

The thrombogenic and haemolytic potential of the heart valve substitute can be assessed using a combination characterization techniques: digital particle image velocimetry (DPIV), computational fluid dynamics (CFD), and ex-vivo methods (e.g. blood loops).

Learn more
<

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.

Learn more
<

Scanning Electron Microscopy (SEM) and Optical Inspection

<

Simulated Use Testing Under Pulsatile Flow

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

Learn more

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