The ViVitro Pulse Duplicator system is the world’s most widely cited and most used in-vitro cardiovascular hydrodynamic testing system.
The ViVitro Pulse Duplicator simulates the function of the heart (left or right) by generating pulsatile flow through prosthetic heart valves placed in the Model Left Heart. Powered by the ViVitro SuperPump, it is composed of the ViVitro Model Left Heart, SuperPump, Flow Measuring System and ViViTest data acquisition system. The components work together to assess the performance of prosthetic heart valves under simulated cardiac conditions.. The ViVitro Pulse Duplicator System is used by the US Food and Drug Administration and is recognised by regulatory bodies worldwide including TÜV, BSI and the Chinese SFDA.
The Pulse Duplicator System assesses the performance of cardiovascular devices and prosthetic heart valves under simulated cardiac conditions. It simulates physiological or other complex flow variations while allowing the user to vary the peripheral resistance and compliance of the system. Pressure ports and flow measuring locations allow for data to be collected from aortic or mitral sites. Transparent viewpoints allow multiple viewing angles of the valve including inflow and outflow.
Combined with the ViVitest software control system, it quickly, easily and reliably collects and analyzes physiological flow and pressure data. The ViVitest software also allows the user to
easily modify and customize waveforms.
Contact Us for a more comprehensive understanding of how the ViVitro Pulse Duplicator can be customized to expand and enhance your device testing capabilities.
Testing Capabilities and Applications
• Transcatheter valves (Aortic or Mitral)
• Surgical valves (Mechanical and Biological)
• Stentless valves
• Structural heart and peripheral vascular devices
• Occluder and Closure Devices (with customization)
• Evaluate LVAD or other assist devices (with customization)
The ViVitro Model Left Heart emulates the pressures and flows of the left heart allowing insertion of valves and other devices into the Pulse Duplicator system for testing. It includes transparent elements to visualize valve function and adjacent flow fields. Ports are available for transducers to measure wall pressures in the left atrium, left ventricle, aortic outflow tract, and downstream of the aortic valve.
The Large Atrium chamber allows devices with an outer diameter of up to 55mm to be tested in the Pulse Duplicator.
• Expands the mitral device testing capabilities of the system
• Quick-release system allows fast device changes
• Accurate flow measurements from flow probe at Atrium inflow
• Enhanced visibility using large viewing window for mitral device inflow
• Customizable Valve Mounting
• Easily added to a ViVitro Pulse Duplicator
ViVitest is part of the ViVitro Data Acquisition System (DAS) family of software products. Combined with the Pulse Duplicator System it collects hydrodynamic testing data to meet ISO 5840 requirements. ViVitest software controls the SuperPump while simultaneously measuring pressure and flow data. It monitors, processes, and reports data such as regurgitant fraction, effective orifice area (EOA), and other valve performance indicators.
A calibration wizard walks new users through the set-up process for quick system preparation for testing. Output files are available in .CSV format for easy analysis in Excel and MatLab.
The ViViTest control system inputs a waveform to the SuperPump while the data acquisition system captures and analyzes physiological pressures and valve flow rates.
ViVitro QCtest checks valve performance against user defined acceptance criteria. It is a turn-key, validated function test software system. The software is easy to use and can be paired with a specific Function Tester Load Assembly on the ViVitro Pulse Duplicator, for quick valve change-outs. This combination is a ready-to use solution for one of the most time-consuming aspects of production to validate.
The QCtest software system was developed as a quality control tool for QC performance testing (function testing) of cardiovascular devices such as heart valves. This production tool provides fast, reliable results at a fraction of the cost of designing and validating an in-house system.
The ViVitro Aortic Conduit Mount (formerly LVOT) can be used to mount a compliant aorta and test percutaneous valves in the ViVitro Model Left Heart system. A variety of Aortic Conduit Mount sizes can be custom made to accommodate silicone tubes with relaxed tube IDs of 12-29 mm. A tube may be expandable up to about 50mm OD.
Available in the following sizes: 12, 14, 16, 18, 20, 22, 24, 26, 28, and 29 mm ID.
The Inflator Syringe includes a plunger lock and fine threaded adjustment for easier pressure calibration of the ViVitro Data
• 25 mL barrel volume
• Locking plunger
• Fine adjustment by means of the threaded plunger knob
The ViVitro Data Acquisition System includes 3 Utah Medical 6069 Pressure Transducers. Additional Pressure Transducers can be ordered separately.
A cable test-port allows for easy verification of monitoring system accuracy and reusable interface cables are available for most every monitor.
The ViVitro Heat Exchanger allows heating of test fluid with minimal interference of the fluid flow.
The Heat Bath Temperature Controller delivers rapid fluid heat-up, optimized for the ViVitro Pulse Duplicator. These heated circulating baths feature a long life, high-wattage heater.
A digital thermometer allows easy fluid temperature measurement in the Pulse Duplicator.
ViVitro offers two standard methods of deploying percutaneous devices into the Pulse Duplicator system; either Transfemoral or Transapical access (Aortic and Mitral). Additional methods can be customized by ViVitro or third party specialists.
Percutaneous Catheter Access enables the deployment of transcatheter devices in an active Pulse Duplicator while the flow loop is operating under pressure. The Percutaneous Catheter Access is designed to accommodate up to 26 French deployment devices and mounts easily to a ViVitro Model Left Heart.
• Transapical access can be rotated to access aortic
or mitral valves
• Catheter insertion with little to no fluid loss during
• Replaceable valves
• Easy to disassemble and clean
This precision, handheld, digital pressure reference manometer conveniently calibrates pressure transducers. Can be re-calibrated in the field for zero, span, and linearity.
The ViVitro Function Tester provides a simplified system that assesses valve performance criteria for production quality control. It is an add-on to the ViVitro Pulse Duplicator and is intended for Production / QC applications.
The Function Tester quickly captures reliable results for a fraction of the cost of designing an in-house system. In conjunction with QCtest software, the Function Tester assesses pressure and flow criteria while recording high speed valve footage via an integrated camera.
Features & Applications