Vivitro Labs Inc.

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Cardiovascular device testing is becoming more and more important as it determines the safety, efficacy and structural integrity of devices. Device manufacturing companies have to meet the increasingly stringent standards set by standards and regulatory agencies such as: U.S. Food and Drug Administration, ASTM International, International Organization for Standardization and Association for the Advancement of Medical Instrumentation.

Contents

History

ViVitro Labs Inc. provides prosthetic heart valve test equipment and laboratory testing, consulting and engineering services. These services & products are extremely useful for people that are being treated for a numerous number of cardiovascular diseases. More specifically, people that have stents and prosthetic heart valves in them.
Vivitro Labs Logo [1]
Vivitro Labs Logo [1]

The company is located in Victoria, British Columbia, Canada and was founded by David Walker and Larry Scotten in 1984. The initail ViVitro test equipment to evaluate a heart valve manufactured at Victoria’s Royal Jubilee Hospital’s Cardiac Development Lab in the mid-1970s. At that time, there was very little documented success developing pulsatile flow testing equipment, David and Larry saw this as an engineering challenge and developed the worlds first commercial pulse duplicator in 1984 [1][3]

ViVitro Labs became a part of Starfish Medical, a service provider in the medical device industry in March 2009. In January 2012 it became the first laboratory in the world to be accredited for performing ISO 5840 hydrodynamic, durability and flow visualization assessments for heart valves.

Services & Products

Pulse Duplicator

The Pulse Duplicator is often used as a physiological heart model to generate peripheral flows and evaluate LVADs or other assisting devices. It is also used to assess the fluid mechanic performance of heart valve replacements and monitor valve performance in terms of load to the heart and potential for blood stasis and damage. [1]

The Vivitro Labs Pulse Duplicator [1]
The Vivitro Labs Pulse Duplicator [1]

The ViVitro Pulse Duplicator is the world’s most widely used heart model, and incorporates the functional capability to test two heart valve substitutes simultaneously in left or right heart configurations while assessing performance and function under simulated cardiac conditions. Powered by a piston-in-cylinder pump head driven by a digital motor with a high torque to inertia ratio, this design provides long lasting and virtually maintenance free reliability [5] Devices being tested:

  • Percutaneous valves
  • Stentless valves
  • Stented tissue valves
  • Mechanical valves
  • Venous valves


HiCycle Durability Tester

As the name suggests, it is used to determine continued structural integrity of replacement heart valves and other cardiac devices under in vivo conditions. It provides useful information on the durability of cardiac devices when subjected to mechanical fatigue. The test is designed to simulate the device radial fatigue due to expansion and contraction of the surrounding vessel.

The Vivitro Labs HiCycle Durability Tester [1]
The Vivitro Labs HiCycle Durability Tester [1]

Physiological strain of a healthy vessel at normal heart rate is first modelled using mock arteries implanted with the device. The test is then accelerated to obtain results in less time than physiological rates would allow. The test is conducted under simulated physiological conditions with saline at 37C (Body temperature) [3]

Devices being tested:

  • Heart Valve Replacements
  • Venous Valve Replacements
  • Septal Defect Devices
  • Cardiac Patches or Strips Medical Sutures
  • Staples or Clips

SuperPump

A super pump system duplicates physiological or other complex pressure variations to provide detailed quality data return to software for heart valve and system It provides realistic pulsatile flow as well as a programmable waveform and playback system, allowing the user live cardiac output control through a standalone system [5]

The Vivitro Labs Pulse Duplicator [1]
The Vivitro Labs Pulse Duplicator [1]

Devices being tested:

  • Heart valve replacements
  • Peripheral devices
  • Vascular devices
  • Aortic Valve By-Pass
  • LVAD simulator



Typical testing time varies from 30-45 days for regular flow visualization tests. However tests can take up to 280 days for Quasi Real-time Durability tests. The tests are performed in saline soultions.

Advantage & Disadvantage of Testing

In vitro valve performance data have the disadvantage that they may not completely simulate the in vivo performance but the advantage of a consistent testing platform for each valve [1]

Other Services

They also provide:

  • Comprehensive laboratory services
  • Advanced engineering services
  • Consulting services
  • Custom Mechanical Tests

Tests and software can be customized for any device, and of there are no established protocols they will work to ensure they meet various company guide lines

All their products have accompanying software available to fully maximize their use.

Clients & Funding

Vivitro labs have clients in over 40 countries, some of which include:

  • Medical Implant Mechanics
  • California Healthcare Institute
  • Victoria Royal Jubilee Hospital
  • Dept. of Mechanical Engineering, University of Ottawa


They are also recipients of a number of grants, most recently a $50,000 grant from the National Research Council, Canada

Future Projects

There is currently no information regarding any future projects, most likely due to issues of patents and copyright

References

[1] "The Industry's First Choice and Last Word in Heart Valve Testing." ViVitroLabs. Web. 24 Feb. 2012. <http://vivitrolabs.com/>.

[2] "Cardiovascular Disease Statistics." Heart Disease Home Page. Web. 24 Feb. 2012. <http://heart-disease.emedtv.com/cardiovascular-disease/cardiovascular-disease-statistics.html>.

[3] "In Vitro Pulsatile Durability Testing." Medical Device Testing Services. Web. 12 Mar. 2012. <http://www.devicetesting.com/pulsatilefatigue.cfm>.

[4] "Cardiac Implants." Marketresearch.com. Freedonia Group, 1 Sept. 2008. Web. 13 Mar. 2012. <http://www.marketresearch.com/Freedonia-Group-Inc-v1247/Cardiac-Implants-1901488/>.

[5] "ViVitro Labs Pulse Duplicator - ViVitroLabs Inc." By Vivitro Labs. Web. 13 Mar. 2012. <http://www.hotfrog.com/Companies/Vivitro-Labs/ViVitro-Labs-Pulse-Duplicator-ViVitroLabs-Inc-691990>.

[6] Roger, L.V., et al. "Heart Disease and Stroke Statistics – 2011 Update: A Report From the American Heart Association." Circulation. 2011; 123:e18-e209.

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