ViVitro Labs

ViVitro Labs Inc. offers industry-leading cardiovascular test equipment and related laboratory testing and consulting services. Hundreds of organizations in over 40 countries for over 30 years have trusted ViVitro expertise, accuracy, and quality for their heart valve, LVAD, TAH, stent, and graft testing.ViVitro Laboratory Services holds ISO/IEC 17025 accreditation based on ISO 5840. ViVitro products are manufactured by StarFish Medical. ViVitro’s A2LA Scope of Accreditation includes the physical and mechanical testing of heart valve substitutes.The ViVitro team brings extensive cardiovascular testing, commercialization, and regulatory experience to your project including cGMP, GLP, GCP, and ISO 17025. Lab Manager, Rob Fraser is a member of the ISO/TC 150/SC 2 – Cardiovascular implants and extracorporeal systems ISO 5840 committee. Technical and Customer Support Trainer, Michael Harding has been intimately involved with the manufacture and support of ViVitro products since 2009.As part of the StarFish Group, our core team is supported and supplemented by Canada’s largest medical device designer and manufacturer, StarFish Medical.ViVitro Laboratory Services holds ISO/IEC 17025 accreditation based on ISO 5840. ViVitro’s A2LA Scope of Accreditation includes the physical and mechanical testing of heart valve substitutes.

Website: vivitrolabs.com/

Address: 455 Boleskine Rd Victoria British Columbia V8Z 1E7 CA

Industry Role

Testing

Areas of Expertise

Cardiovascular

Product Lines

ViVitro SuperPump

The ViVitro SuperPump is a digitally controlled hydraulic piston 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.

ViVitro Pulse Duplicator

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.

ViVitro HiCycle Durability Tester

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.

ViVitro Real-Time Wear Tester (RWT)

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.

Hitest Data Acquisition System

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.

ViVitro Endovascular (EV) Simulator

The ViVitro Endovascular (EV) Simulator creates physiological pulsatile flow and pressures for testing many types of cardiovascular devices. It addresses requirements of ISO 5840, ISO 25539, and ISO 7198 standards as they include simulated use guidelines. Use the EV Simulator in simulated-use testing and simulation training of cardiovascular devices.

Control a live cardiac flow in a standalone configuration. Using the ViVitro SuperPump, EV 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.

ViVitro QCTest

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.

Lab Testing Services

Durability Testing

We offer unlimited capacity for ISO 17025 accredited durability assessment and expedite time to market. Our bank of HiCycle durability testers allows millions of test cycles to be accumulated in a short period of time. ViVitro Real-Time Wear Testers provide quasi-real-time rates for additional physiological failure mechanism data.

Hydrodynamic Testing

Whether for quick design iteration feedback or 3rd party independent testing for regulatory approval, ViVitro Laboratory Services offers fast turnaround times. Testing is conducted on all types of cardiovascular devices in accordance with applicable standards and regulations. ViVitro offers both pulsatile and steady flow testing which are ISO 17025 Accredited by A2LA.

Customized Testing

In-house experts develop testing solutions unique to your device ensuring the right tests are conducted to determine device safety and efficacy.

Customized laboratory testing services provide immediate tailored solutions when experience is vital to drive progress.

Key Personnel

Scott Phillips, CEO

Gerry Wight B.Eng, General Manager

Vesna Janic, Director of QA

Rob Fraser, MSc., Lab Manager

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