Pulse Duplicator The world’s most widely-used heart model
Pulse
Duplicator
widely-used heart model
The ViVitro Pulse Duplicator system is the world’s most widely cited and most used in-vitro cardiovascular hydrodynamic testing system of aortic, pulmonary, tricuspid and mitral prosthetic valves
The ViVitro Pulse Duplicator simulates the function of the heart (left or right) by generating pulsatile flow through mechanical, biological, or polymeric prosthetic heart valves placed in the Model Heart (Left or Right). Powered by the ViVitro SuperPump pulsatile pump, it is composed of the ViVitro Model Heart (Left or Right), SuperPump pulsatile pump, 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 and used by regulatory bodies worldwide including TÜV, BSI and Chinese CFDA.
The Pulse Duplicator System assesses the performance of cardiovascular devices and aortic, pulmonary, tricuspid and mitral prosthetic 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 data to be collected on aortic and mitral valves test samples as well as pulmonary and tricuspid valves samples. 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.
The ViVitro Pulse Duplicator System is cited in numerous research studies throughout the world. Visit our Citation Database for the current list of applications and articles.
Read our FAQs:
- 10 ways ViVitro Pulse Duplicator compares to equipment built in-house
- Using the ViVitro Pulse Duplicator for Right Heart Testing
- How do I mount my device in the ViVitro Pulse Duplicator?
Contact Us for a more comprehensive understanding of how the ViVitro Pulse Duplicator can be customized to expand and enhance your device testing capabilities.
Product Code: 18363
Related Part Numbers: SD2001 Model Heart (Left or Right), FS0992 Flow Meter
- Capable of testing a range of prosthetic heart valves including stented tissue, percutaneous, stentless, mechanical, and other valves
- Capable of testing aortic, pulmonary, tricuspid and mitral prosthetic valves
- Flow and pressure readings can be acquired meeting ISO 5840 frequency response and accuracy requirements and analyzed for device performance to ISO 5840 requirements
- Peripheral resistance and supplementary characteristic compliances to simulate cardiovascular character and resistance
- Evaluate LVAD or other assist devices (with customization)
- Test structural heart and peripheral vascular device
- Flow and pressure readings can be collected and analyzed in real-time, meeting ISO 5840 requirements
- Controls pulsatile fluid flows to simulate various cardiac flow conditions including arrhythmia, normal, hypo and hypertensive states at an assortment of cardiac outputs and beat rates
- Transducer sites allow measurement of wall pressures in the atrium, ventricle, and aortic outflow tract
- Flow can be measured directly at the aortic or mitral valve positions
- Flow can be measured directly at the pulmonary and tricuspid valve positions
- Simulates cardiovascular peripheral resistance and compliance
- Thin acrylic windows permit echo imaging, Doppler flow measurements, and PIV for interrogation of flow field regions
- Allows hydrodynamic testing of heart valve replacements in order to assess mechanical and hemodynamic performance
- Ventricle membrane to replicate the natural chamber flow
- Accessories are available for testing other implantable cardiac devices including Occluder and Closure Devices.
Testing Capabilities and Applications
- Mechanical, polymeric and biological surgical valve prosthesis
- Polymeric and biological valve prosthesis for Transcatheter Aortic Valve Replacement (TAVR)
- Polymeric and biological valve prosthesis for Transcatheter Aortic Valve Implantation (TAVI)
- Polymeric and biological valve prosthesis for Transcatheter Tricuspid Valve Replacement (TTVR)
- Polymeric and biological valve prosthesis for Transcatheter Mitral Valve Replacement (TMVR)
- Stentless valves
- Structural heart and peripheral vascular devices
- Occluder and Closure Devices (with customization)
- Evaluate LVAD or other assist devices (with customization)
- Advanced cardiac flow loop systems for pressure and flow monitoring devices
- Flow and pressure readings can be collected and analyzed in real-time, meeting ISO 5840 requirements
- Controls pulsatile fluid flows to simulate various cardiac flow conditions including arrhythmia, normal, hypo and hypertensive states at an assortment of cardiac outputs and beat rates
- Transducer sites allow measurement of wall pressures in the atrium, ventricle, and aortic outflow tract
- Flow can be measured directly at the aortic or mitral valve positions
- Flow can be measured directly at the pulmonary and tricuspid valve positions
- Simulates cardiovascular peripheral resistance and compliance
- Thin acrylic windows permit echo imaging, Doppler flow measurements, and PIV for interrogation of flow field regions
- Allows hydrodynamic testing of heart valve replacements in order to assess mechanical and hemodynamic performance
- Ventricle membrane to replicate the natural chamber flow
- Accessories are available for testing other implantable cardiac devices including Occluder and Closure Devices.
- Mechanical, polymeric and biological surgical valve prosthesis
- Polymeric and biological valve prosthesis for Transcatheter Aortic Valve Replacement (TAVR)
- Polymeric and biological valve prosthesis for Transcatheter Aortic Valve Implantation (TAVI)
- Polymeric and biological valve prosthesis for Transcatheter Tricuspid Valve Replacement (TTVR)
- Polymeric and biological valve prosthesis for Transcatheter Mitral Valve Replacement (TMVR)
- Stentless valves
- Structural heart and peripheral vascular devices
- Occluder and Closure Devices (with customization)
- Evaluate LVAD or other assist devices (with customization)
- Advanced cardiac flow loop systems for pressure and flow monitoring devices
*We recommend connecting the Flow Meter to a different circuit than the Heat Bath. The Flow Meter is a sensitive measurement instrument and the large Heat Bath current draw can cause minor disturbances in the flow measurements when the heater switches on.
- Pump & MLH
- 53 x 92 x 45 cm
- DAS & Flow System
- 48 x 33 x 32 cm
- Dry weight: Actuator +
- Model Heart (Left or Right) + VIA
- 18 kg
- Dry weight:
- Flow Measuring System
- 5.6 kg
- Operating Voltage
- 90-240 VAC / 50-60Hz
- Temperature range
- Ambient to 40°C ± 1.0°C
- Flow rate
- 0 - 15 L/min
- Heart rate
- 3 - 200 bpm
- Valve size Aortic
- Up to 035mm
- Valve size Mitral
- Up to 035mm (*070mm with Large Atrium Accessory)
- Power Consumption
- SuperPump pulsatile pump
- Max 300W
- AmPack
- Max 10W
- Heat Bath*
- Heater Capacity 1.2kW
- Laptop
- ~60W
- Flow Meter*
- 25W
ViVitest Data Acquisition System (DAS)
Product Code: 08530, Related Part Numbers: 08311 I/O Module, AP9991 AmPack
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 pulsatile pump 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 pulsatile pump while the data acquisition system captures and analyzes physiological pressures and valve flow rates. Data Acquisition
- Flow and pressure readings can be collected and analyzed in real time meeting ISO 5840-2:2015, ISO 5840-3:2013 and FDA requirements
- Calibration wizards walk new users through the set up process, facilitating a wide array of data collection options.
- Collects pressure and flow data for complete hydrodynamic performance.
- Provides output files in versatile formats for easy analysis in Excel and MatLab
- Ability to create and control cardiac waveforms at various physiological states and frequencies, including arrhythmia and wave trains
- Waveforms can be easily created with up to 1200 control statements
- Backwards compatible with ViVitro products
- .Net 3 Platform
- Configured for 64-bit Windows 7 & 10 operating systems
- Installer allows for easy updates
- Singular program eliminates the need for intrusive third party software
Product Code: 08530 Data Acquisition System
PN 08311 I/O Module and AP9991 AmPack
Easy-to-read interface
QCtest Software
Product Code: 26066
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 Production 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. Features:- Pass or fail criteria definable using a secure log-in
- Automatically saves pass/fail results along with a report of each test and video
- User definable system calibration intervals
- Simple user interface
Viscoelastic Impedance Adapter (VIA)
Product Code: VIA7991
The ViVitro Viscoelastic Impedance Adapter (VIA) works in conjunction with the SuperPump pulsatile pump to produce more realistic physiological ventricular pressures. It consists of a fixed resistive element and two adjustable compliance chambers to simulate ventricular viscoelastic behavior.
Features:- Adjustable dP/dt ratio to produce both physiological and diseased cardiac models
- Filters high frequency noise when testing prosthetic valves and aortic conduits
- Easily adjusted
- Fixed resistance
- 200 c.g.s. units
- Compliance air volumes
- SOURCE 0-120 ml, OUTPUT 0-60 ml, syringe adjustable
- Total liquid volume
- 500 ml with SOURCE / OUTPUT compliance air volumes zero
- Materials
- Acrylic, Polycarbonate, Delrin, Nylon, Polyethylene, Stainless Steel, Viton
ViVitro Labs Pulse Duplicator Characterization Valve Kit
Product Code: 56468 SJM MECHANICAL, 25MM
ISO 5840-2:2021 and 5840-3:2021 now require performance characterization of pulse duplicator system performance. The ViVitro Labs Pulse Duplicator characterization valve kit includes a ISO 5840:2021 ViVitro Labs Pulse Duplicator characterization test method and St. Jude Master’s valve with certified results for the ViVitro Pulse duplicator.
Features:- St. Jude Master’s Valve
- ISO 5840:2021 ViVitro Labs Pulse Duplicator characterization test method
- Certificate with St. Jude Master’s Valve test method results
Large Atrium Chamber (Mitral)
Product Code: 21179
The Large Atrium chamber allows devices with an outer diameter of up to 70mm 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
Percutaneous Access Device
Transapical Access Product Code: 18496 Transfemoral Access Product Code: 18497
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 34 French deployment devices and mounts easily to a ViVitro Model Heart (Left or Right). Features:- Transapical access can be rotated to access aortic or mitral valves
- Catheter insertion with little to no fluid loss during pulsatile operation
- Replaceable valves
- Easy to disassemble and clean
Left Ventricular Assist Device (LVAD) Accessory
Product Code: 25205
The Left Ventricular Assist Device (LVAD) accessory enables testing of LVAD devices with physiological pulsatile flows generated by the ViVitro Pulse Duplicator. It is an optional add-on to the ViVitro Pulse Duplicator. A ventricular cannulation option is also available. Connection points are ½” hose barbs.
The accessory package includes components which provide connection points for the:- Ventricle apex
- Aortic chamber
PIV Load Assembly
Product Code: 21026
Aortic Particle Image Velocimetry (PIV) Flow Visualization
The PIV Load Assembly provides an optically clear, anatomically representative aortic inflow and outflow to enable Particle Imaging Velocimetry studies in the Pulse Duplicator. The PIV Load Assembly replaces the lower half of the standard aortic load assembly and is easily substituted into the ViVitro Labs Pulse Duplicator.- Optically clear, non-distorting inflow and outflow section
- Interchangeable and customizable silicone aortic annulus
- Anatomical aortic sinuses
- Outflow pressure port
- Easily installed in the Pulse Duplicator
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