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 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 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.
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.
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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.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: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:ISO 5840-2:2021 and 5840-3:2021 now require reference valves to help characterize pulse duplicator system performance. ViVitro Labs offers the valve specified in the standard, mounted in a holder compatible with ViVitro equipment.
Features:The Large Atrium chamber allows devices with an outer diameter of up to 70mm to be tested 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 34 French deployment devices and mounts easily to a ViVitro Model Heart (Left or Right). Features:The ViVitro Aortic Conduit Mount (formerly LVOT) can be used to mount a compliant aorta and test percutaneous valves in the ViVitro Model Heart (Left or Right) 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. The aortic conduit mount accommodates conduit lengths from 44 to 64 mm.
Available in the following sizes: 12, 14, 16, 18, 20, 22, 24, 26, 28, and 29 mm ID.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: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.Specifications
The geometry of the aortic root is based on a reasonable simplification of the average measurements published in manuscripts by Tops (2008) and Buellesfeld (2013) (data procured from MSCT).PIV setup including laser, lenses, high speed camera, and PIV Load Assembly in a Pulse Duplicator.
The ViVitro Production Tester Quality Control System 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 Production Tester quickly captures reliable results for a fraction of the cost of designing an in-house system. In conjunction with QCtest software, the Production Tester assesses pressure and flow criteria while recording high speed valve footage via an integrated camera.
Features & ApplicationsThe 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.This precision, handheld, digital pressure reference manometer conveniently calibrates pressure transducers. Can be re-calibrated in the field for zero, span, and linearity.
The Inflator Syringe includes a plunger lock and fine threaded adjustment for easier pressure calibration of the ViVitro Data Acquisition System.
• 25 mL barrel volume • Locking plunger • Fine adjustment by means of the threaded plunger knobThe 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.