The ViVitro HiCycle Durability Tester is used to determine the durability of replacement heart valves and other cardiac devices under physiological loading for R&D and regulatory submissions.
With the Hitest Data Acquisition System, operators can monitor pressure and collect data according to ISO 5840 standards.
The HiCycle system uses an electrodynamic motor driving six pistons within fluid-filled, temperature-controlled chambers to move the device rather than the fluid. This results in higher energy efficiency and stable fluid flow. The devices can be cycled at accelerated rates up to 1,650 cycles/minute.
Clear viewports allow imaging of the device during testing, and pressure ports allow monitoring of the dynamic pressures upstream and downstream of the device.
Each test chamber is independent of the others to offer testing flexibility.
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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.
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The ViVitro SuperPump is a digitally controlled hydraulic piston pulsatile pump that creates physiological cardiac flows. Unsurpassed in reliability, functionality, and versatility, the AR Series digital technology provides maximum control with precision accuracy. The SuperPump works with ViVitro or independently produced accessories to create reliable cardiac flows for any type of cardiovascular device.
The ViVitro SuperPump is used in numerous studies throughout the world. Visit our Citation Database for the current list of applications and articles.
The SuperPump provides maximum operator control with precision accuracy. The pump can be controlled by preconfigured waveforms or by customizable ViViTest software input.
The SuperPump AR is pre-loaded with up to 5 waveforms stored on the controller which enables the pump to be used as a standalone device. Custom waveforms may also be stored on the controller for standalone use.
The ViVitro SuperPump AR Series can be driven by external waveform sources giving flexibility for waveform input. Function generators, personal computers with I/O functionality, custom hardware, microcontroller development boards, and even smartphones can directly control the flow output of the pump. SuperPump feedback can be captured using an oscilloscope or other acquisition device to monitor waveform accuracy. A major advantage of the ViVitro Labs SuperPump AR is its ability to accurately follow user-defined waveforms. The system can provide accurate flows for a wide variety of applications.
Our new data sheet explains this in detail. Here are some highlights:
There are four options for running our fluid pump with waveforms:
Contact us for more details about how the ViVitro SuperPump can expand and enhance your device testing capabilities.
• Heart valve function testing
• Peripheral devices
• Vascular devices
• Aortic Valve By-Pass
• LVADs simulator
• Flow transducer evaluation/calibration
• Isolated heart driver
• Echo Doppler flow phantom
• Neurovascular studies
• Blood vessel flow studies
• MRI studies
• Bioreactors & Incubators
• Applications requiring physiological flows and pressure
• Other cardiovascular devices
The ViVitro Real-Time Wear Tester (RWT) is a quasi-real-time wear tester for heart valve replacements, venous Valve replacements, occluder devices, cardiac patches or strips, medical sutures, staples or clips, and other cardiovascular devices. It can be customized for devices and device mounting arrangements (including conduit mounted valves and large prosthetic heart valves).
The RWT gives users full control over the waveform driving the system while testing numerous devices simultaneously.
With the Hitest Data Acquisition System, RWT operators are able to collect and analyze pressure data according to ISO5840 standards through an intuitive user interface. Quasi-real-time results may identify failure modes similar to animal tests for prosthetic heart valves.
Read our FAQ: How do I mount my device in the ViVitro RWT?
Contact us for a more comprehensive understanding of how the ViVitro Real-Time Wear Tester can expand and enhance your device testing capabilities.
The ViVitro QCTest program is the only turnkey validated function test software system available. 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.
QCTest operates through a USB Multifunction Measurement and Control Board, compatible with 64-bit operating systems.
The QCTest software system was developed as a quality control tool for QC heart valve function testing. This production tool enables fast, reliable results for a fraction of the cost of designing and validating an in-house system. QCTest measures valve performance in accordance with regulatory requirements.
QCTest includes security, risk management, simplified user interface, error checking, control steps and standard disposition outputs. QCTest function test software was developed by ViVitro and meets validation requirements outlined in the FDA General Principles of Software Validation; Final Guidance for Industry, document.
Contact us for more information about how QCTest software or ViVitro’s engineering staff can assist you with Function Testing to meet your Quality Control needs.
The ViViFlow Electromagnetic flow meter accurately measures flow for testing, research and laboratory applications. Platform independent, the flow meter can be used separately, or with the ViVitro Pulse Duplicator or Endovascular Simulator. It is compatible with the ViVitro I/O module and Data Acquisition System.
The ViViFlow offers the following benefits:
The ViVitro Endovascular Simulator creates physiological pulsatile flow and pressures for testing many types of cardiovascular devices and can be used for any portion of the cardiovascular system.
Our vascular flow platform brings physiological pulsatility to anatomical models for research and development. The simulator can easily be reconfigured for bench top, cath lab or portable cart installation.
The Endovascular Simulator addresses requirements of ISO 5840, ISO 25539, and ISO 7198 standards as they include simulated use guidelines.
Control a live cardiac flow in a standalone configuration. Using the ViVitro SuperPump, the Endovascular Simulator’s programmable waveform system delivers physiological pulsatile flow. Test a variety of endovascular medical devices and delivery systems by adding anatomical models, including abnormalities or custom patient-specific models.
Use the ViVitro Endovascular Simulator to demonstrate that devices can be delivered and deployed in a safe, consistent and accurate manner within the intended implant site and with intended use conditions.
Endovascular simulation training
The Endovascular Simulator offers a clinically relevant practice model for physicians. Visible anatomy provides feedback while navigating anatomical structures and abnormalities that may be encountered during actual procedures.
Physicians sharpen their skills and increase their confidence in a safe and realistically simulated environment. Learning a delivery system while experiencing physiological pulsatile flow and pressures encountered when maneuvering stents, catheters, wires, balloons, heart valves and other endovascular devices instills invaluable feedback.
Contact us to learn how the ViVitro Labs EV Simulator can facilitate your device testing and training challenges.