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Services » Hydrodynamic Testing

Hydrodynamic Testing

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. ViVitro offers both pulsatile and steady flow testing which are ISO 17025 Accredited by A2LA.

Pulsatile Flow

Using the ViVitro Labs Pulse Duplicator or ViVitro Labs SuperPump 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.

 

Steady Flow

Using the ViVitro Labs steady flow bench, we test for steady forward flow or reverse flow leakage.

  • Forward flow pressure drop can be measured at flow rates ranging from 0.5-30 LPM
  • Steady back pressure leakage testing can be conducted at pressures ranging from 5-350 mmHg
  • Burst testing can also be conducted to measure the hydrostatic load at which failure occurs, this is a useful tool for determining failure modes of devices.

Valves (Transcatheter, Biological, Mechanical, Venous, Conduits)

Pulsatile Flow (ISO 5840-3:2013 N.4, ISO 5840-2:2015 F.4)

Obtain key indicators of valve performance including regurgitant fraction, effective orifice area, and numerous others. ViVitro’s standard test methods include testing at various beat rates, cardiac outputs, and back pressures. In addition to pass/fail information in accordance with ISO 5840, these methods can show design parameters such as minimized paravalvular leakage, transvalvular leakage, closing volume, leakage volume, and forward flow pressure drop. Along with quantitative data, ViVitro can provide qualitative high speed video and high resolution photography of a device while operating, providing key information on valve performance.

Steady back-flow leakage testing (ISO 5840-3:2013 N.3, ISO 5840-2:2015 F.3)

The leakage rate through a device can be measured at constant back pressures. Testing can be conducted to determine paravalvular vs intravalvular leakage.

Steady forward flow testing (ISO 5840-3:2013 N.2, ISO 5840-2:2015 F.2)

A recommended study for transcatheter valves, steady forward flow testing is useful in verifying the accuracy of the pulsatile flow test as the pressure drop across a test valve is measured at various flow rates.

Burst Test (ISO 5840-2:2015 H.6)

Used for determining failure modes of devices, a Burst Test measures the hydrostatic load at which valve failure occurs.

Other Cardiovascular Devices

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.

 

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 including:

  • Ventricular Assist devices (VAD, LVAD, RVAD) (ISO 14708-5:2010 Annex DD)
  • Total artificial hearts (TAH) (ISO 14708-5:2010 Annex DD)
  • Occluders or Closure Devices (ASD – Atrial Septal Defect, PFO – Patent Foramen Ovale, ASO – Atrial Septal Occluder, VSD- Ventricular Septal Defect, PDA Patent Ductus Arteriosus, PLD- Paravalvular Leakage Device)
  • Valvular repair or reconstruction devices
  • Conduits
  • Shunts
  • Intra-aortic balloon pumps

 

Hydrodynamic Testing (640x501)

 

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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. We work to your schedule and deliver to our commitments. We design unique tests to meet specific developmental needs.

ISO 17025 Accredited by A2LA
For studies used for regulatory approval this is a must. Our trained researchers, calibrated equipment, and internal audits meet ISO 17025 standards.

Free Set-Up Consultations
All of our feasibility studies are developed 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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