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.
Using the ViVitro Labs Pulse Duplicator or ViVitro Labs SuperPump we are able to document pressure and flow performance characteristics of your device at:
Using the ViVitro Labs steady flow bench, we test for steady forward flow or reverse flow leakage.
Using the ViVitro Endovascular Simulator, we can create physiological pulsatile flow and pressures to test many types of cardiovascular devices and any portion of the cardiovascular system. Our vascular flow platform brings physiological pulsatility to anatomical models for research and development.
The Endovascular Simulator addresses requirements of ISO 5840, ISO 25539, and ISO 7198 standards as they include simulated use guidelines.
Our lab can control a live cardiac flow in a standalone configuration. We can 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.
Our lab team has used the Endovascular Simulator to perform tests including the following applications:
Obtain key indicators of valve performance including regurgitant fraction, effective orifice area, and numerous others. ViVitro’s standard test methods include testing at various beat rates, cardiac outputs, and back pressures. In addition to pass/fail information in accordance with ISO 5840, these methods can show design parameters such as minimized paravalvular leakage, transvalvular leakage, closing volume, leakage volume, and forward flow pressure drop. Along with quantitative data, ViVitro can provide qualitative high speed video and high resolution photography of a device while operating, providing key information on valve performance.
The leakage rate through a device can be measured at constant back pressures. Testing can be conducted to determine paravalvular vs intravalvular leakage.
A recommended study for transcatheter valves, steady forward flow testing is useful in verifying the accuracy of the pulsatile flow test as the pressure drop across a test valve is measured at various flow rates.
Used for determining failure modes of devices, a Burst Test measures the hydrostatic load at which valve failure occurs.
Many new classes of repair devices do not have testing standards like more established technologies. We excel at breaking down a complex device and pathophysiology into a justifiably simplified bench top test. Each will have well defined:
Our test plans and reports are designed around approval bodies, thoroughly researched, and justified to ensure they are regulatory appropriate. Contact us today to discuss your cardiovascular testing needs including:
Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:
Time to Market
We understand how critical your timelines are. We work to your schedule and deliver to our commitments. We design unique tests to meet specific developmental needs.
ISO 17025 Accredited by A2LA
For studies used for regulatory approval this is a must. Our trained researchers, calibrated equipment, and internal audits meet ISO 17025 standards.
Free Set-Up Consultations
All of our feasibility studies are developed via no-cost, no obligation, collaborative consultation.
We happily provide Non-Disclosure Agreements for all services, including initial consultation.