Heart Valve Prosthesis
Accelerated Wear Testing with

VIVITRO LABS INTRODUCES ITS NEW AWT-V8 SYSTEM WITH DUAL CONTROL TECHNOLOGY (DCT)™

ViVitro Labs continues to innovate in the field of heart valve prosthesis testing and sets a new gold standard for accelerated wear testing by addressing the limitations of older 1st and 2nd generation AWT test systems on the market.

NEW

FIRST AWT SYSTEM TO ALLOW EARLY DETECTION OF HEART VALVE PROSTHESIS FATIGUE FAILURE

The new ViVitro Labs AWT-V8 with Dual Control Technology (DCT)™ is the first AWT system designed to automatically detect the onset of valve fatigue failure before any hydrodynamic inspection points and significantly shorten R&D development time. The Historical Data View leverages the advanced dual pressure control technology of the ViVitro Labs AWT-V8 system to offer uninterrupted valve health monitoring during AWT studies and automatically alerts users of potentially undesirable fatigue related events during testing.

The software integrated Historical Data View allows users to:

• Detect subtle changes in valve behavior by continuously monitoring the system bypass valve.
• Continuously monitor the progression of critical AWT study parameters to determine the exact time of events.
• Streamline viewing and analysis of large data sets in support of any subsequent root cause analysis.
• Monitor AWT system health during studies and efficiently direct system maintenance interventions when required.

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NEW

FIRST AWT SYSTEM TO GENERATE CONSTANT LOADING CONDITIONS AT VALVE CLOSURE AND OPENING WHILE BRINGING 100% CONFIDENCE THAT CYCLES HAVE ACHIEVED ISO 5840 REQUIREMENTS

The ViVitro AWT-V8 System with DCT™ is a fully software-controlled instrument with a proprietary user-friendly interface to control and maintain AWT test conditions specified in ISO 5840. The ViVitro Labs AWT-V8 System uses two separate position feedback sensors and algorithms to automatically control the piston displacement and the bypass valve independently for up to 6 independent test modules with pure standalone architecture.

The ViVitro Labs AWT-V8 system with DCT™ regulates the differential pressure across the valve sample independently of the stroke volume using two separate control mechanisms. By keeping the stroke volume constant, the loading conditions at valve closure and opening can be kept constant and stable throughout the duration of the AWT study. At the same time, to mitigate the effect of the pressure variation due to valve wear, the bypass valve automatically regulates the differential pressure across the valve with minimal impact on leaflets kinematics. By controlling stroke volume throughout the AWT study, the ViVitro Labs AWT-V8 system with DCT™ locks the driving parameter that affects valve motion and strains experienced by leaflet materials the most. The independent control of the bypass valve optimizes the differential pressure across the test sample with minimal impact on valve motion while optimizing passing cycles. Upon completion of the cycling period, valve prosthesis samples have been subjected to constant loading conditions at valve closure and opening with a highly reliable passing cycles count. At the end of the AWT study customers have 100% confidence that cycles have achieved ISO 5840 requirements.

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NEW

FIRST AWT SYSTEM TO INTEGRATE SIDE-BY-SIDE LIVE KINEMATIC ASSESSMENT OF HEART VALVE PROSTHESIS DURING FATIGUE STUDIES

The ViVitro Labs software integrated AWT-V8 Valve Comparison Tool simplifies and streamlines the assessment of valve kinematics to increase the reliability of AWT test results. Users can efficiently and reliably determine which AWT test conditions produce the desired valve opening position by comparing any pre-recorded real-time valve kinematics videos side-by-side with a live High-Speed (HS) camera stream from the AWT system. The ViVitro Labs AWT-V8 with DCT™ combines the action of a High-Speed Camera with an adjustable intensity annular LED light, a Micrometric Rail Support System and an integrated Valve Comparison software interface to simplify video capture and provide utmost consistency in valve kinematics assessment. The side-by-side comparison allows users to quickly and conveniently compare valve motions between samples at any point during a durability study.

The ViVitro Labs AWT-V8 Valve Comparison Tool allows side-by-side kinematics assessment of valve samples at different points in time to:

• Determine AWT test conditions leading to maximum valve opening position during the AWT tuning phase by comparing pre-recorded video segments under physiological conditions against live HS camera streams under accelerated conditions.
• Determine test sample wear trends under accelerated conditions by comparing pre-recorded video segments against live HS camera streams at any point in time.
• Retrospectively, determine test sample wear trends under accelerated conditions by comparing pre-recorded HS Camera video segments against each other both at any point in time.
• Retrospectively, determine test sample wear trends under physiological conditions by comparing pre-recorded video segments against each other at any point in time before or/and after hydrodynamic inspection.

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NEW

FIRST AWT SYSTEM TO ENABLE SMART AT-A-GLANCE OVERVIEW OF THE STATUS OF MULTIPLE AWT TEST MODULES

The ViVitro Labs AWT-V8 Dashboard View increases the efficiency of laboratory resources dedicated to the management of AWT systems by quickly guiding user interventions only when and where they are needed. The ViVitro Labs AWT-V8 Dashboard View provides an at-a-glance overview of the status of each test module without navigating through multiple system screens and inefficiently searching for study parameters during AWT studies. AWT-V8 Dashboard View is a tool to optimize laboratory resources and boost efficiency in management of AWT studies.

The ViVitro Labs AWT-V8 system Dashboard View user-friendly software interface was designed to direct users when conducting AWT studies with multiple chambers. The integrated AWT System Dashboard View greatly simplifies the AWT systems management and reduces user error during sensitive studies. With an easy to spot color scheme and visual alarms, the ViVitro Labs AWT-V8 system Dashboard View provides an at-a-glance live overview of all standalone test modules test parameters, and system status.

The ViVitro Labs AWT-V8 system Dashboard View is also equipped with visual indicators to instantly flag users when:

• the standalone test module pressure is not meeting target (5% rule)
• the standalone test module temperature is out of range
• study and system alarms are triggered
• data logging is disabled or paused

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