System Characterization

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

Test Procedure

Whether for quick design iteration feedback or 3rd party independent testing for regulatory approval, ViVitro Laboratory Services offers fast turnaround times. Testing is conducted on all types of cardiovascular devices in accordance with applicable standards and regulations.

 

Many new classes of repair devices do not have testing 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 [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.

 

 

Equipment

Using the ViVitro Labs Pulse Duplicator or ViVitro Labs SuperPump pulsatile blood pump we are able to document pressure and flow performance characteristics of your device at:

  • Cardiac Outputs of 0.5- 15 LPM
  • Beat rates of 3-200 BPM
  • Systolic durations ranging from 30-50%
  • Back pressures up to 350 mmHg
  • Depending on the device we can simulate different pathophysiologies including hypertension, hypotension, arrhythmias, to name a few.

Scope

  • Ventricular Assist devices (VAD, LVAD, RVAD) (ISO 14708-5:2010 Annex DD)
  • Total artificial hearts (TAH) (ISO 14708-5:2010 Annex DD)

Service Levels

Applicable Standards

  • ISO 14708-5:2020
    Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices

Related Tests

OLE/QV


ViVitro Labs Advantages

Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:

Time to Market
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Accredited by A2LA and Cofrac.

Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.

Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.

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