Highlights: ISO 17025 Interview with Dr. Bassil Akra, Rob Fraser joins ISO/TC Working Committee, Introducing our new N.A. Major Accounts Manager, TCT 2015, Maralidhar Padala on new mitral valve disease technologies and solutions, New HiCycle bellows durability, MD&M Minneapolis, FAQ: In-house equipment comparison, Qualification Services, Interview with Dominik Obrist on bio-medical fluid dynamicist approach, Product leasing, ISO 5840-1 and 5840-2 released, Training in your facility, Revised Pulse Duplicator Manual and more.
VNews - Cardiovascular Device Testing News, brought to you by ViVitro Labs

Gerry's Welcome

It has been a great summer and I enjoyed staying at home in Victoria to take in all it has to offer. I still feel like I didn’t get enough biking, beach time or mini golf though!

We were very pleased to have a number of customers come visit us during the summer and several interviews are included below on the interesting research they are doing using our products. 

Now my daughters are back to school and it is time to start thinking about TCT in San Francisco, October 12-14, 2015, and MD&M Minneapolis, November 4-5, 2015.
A number of new products and services are highlighted in this issue to better support you in your research and maximize the value you get from our products. New services include: short term product leasing, customized on-site training, product calibration and qualification services.

On the product side we have been equally busy. A new bellows design for the HiCycle, an updated Pulse Duplicator product manual and a few more product announcements to reveal at TCT made summer fly by.
Thanks for taking the time to read our update and I hope to catch up with you in San Francisco.

Gerry Wight
General Manager
1 (250) 388 3531
Team from University of Free State, South Africa learns how to image flow using ultrasound on ViVitro pulse duplicator.

 Training at your facility

University of Free State, South Africa team learns how to image flow using ultrasound on a ViVitro Pulse Duplicator in the photo above.

Two day Pulse Duplicator product training at your offices is more affordable than you think.  

Essentials of the system including:
  • Assembly and Setup
  • Running the system
  • Collecting Data
  • Cleaning and Maintenance.
In addition to the Pulse Duplicator course, we also offer a one day HiCycle training course. 
Real Time Wear Tester

New HiCycle bellows 65% more durable

Our new HiCycle bellows have 65% greater durability.

The bellows use a new compound of silicone, have the same geometry as previous versions, and are backward compatible with all HiCycle systems.

They are $100 USD each and are available now. All new HiCycle systems and Spare Parts Kits will include the new bellows.

If you wish to purchase the new bellows, please contact us and reference part number 21056.

ViVitro at MD&M Minneapolis 2015
Our final show for 2015 will be at MD&M Minneapolis, Nov 4-5.  We will be featuring our updated Pulse Duplicator system with options for Mitral valves, QA / Production testing and our new flow meter in booth 2512.

Booth visitors can enter to win an Apple Watch. 

Joe McMahen,  and Doug Bigrigg will be there. If you would like to set up a time to meet during or after the show please send Doug an email.  

Qualification Services

Operational Qualification service is available for several ViVitro products and systems. The service
can be provided on-site at your facility or included as part of a factory repair.

The following products can be calibrated by ViVitro:
• Ampack
• HiCycle
• SuperPump

We recommend system operational qualification be performed annually.

Download data sheet

Short Term Product Leasing

Short term product leases (up to 6 months) are available for SuperPump or
HiCycle Durability Tester equipment:

Use a short term lease to: 

• Evaluate equipment 
• Conduct one-off testing
• Add temporary testing capacity
• Continue projects during a repair

Download a data sheet

Revised Pulse Duplicator Manual now available

The newly revised Pulse Duplicator User Manual has been reformatted and substantially updated.
  • Improved Calibration information
  • More detailed ViViTest operation section  
  • Improved Step By Step Guide

Interview: Dr. Bassil Akra on ISO 17025 and the differences in North American and European regulations

Dr. Bassil Akra

Dr. Bassil Akra, Director Clinical Centre of Excellence (cCE) at TÜV SÜD Product Service GmbH, was in Vancouver BC for a recent ISO meeting and took the opportunity to visit customers and ViVitro Labs.  

Rob Fraser, Lab Manager, MSc. at ViVitro Labs, spoke with Dr. Akra about the differences in North American and European regulations. 

Rob Fraser joins Standards Council of Canada as Cardiovascular Working Committee member

Rob Fraser
Rob Fraser, Msc., has been accepted and registered as a Standards Council of Canada (SCC) Member to ISO/TC 150/SC 2 – Cardiovascular implants and extracorporeal systems (ISO 5840) committee. ViVitro is proud that our Lab Manager, Rob, is one of only two Canadian members on the committee.

“I joined the ISO/TC 150/SC 2 – Cardiovascular implants and extracorporeal systems committee to better guide ViVitro clients with any hurdles, keep up with industry trends and make sure our clients’ needs and concerns were addressed in the evolving regulatory requirements,” explains Mr. Fraser.    

ISO 5840-1 and 5840-2 are released for publication

ISO 5840-1:2015 Cardiovascular implants -- Cardiac valve prostheses -- Part 1: General requirements, and ISO 5840-2:2015 Cardiovascular implants -- Cardiac valve prostheses -- Part 2: Surgically implanted heart valve substitutes were released for publication on September 15, 2015, during the Berlin working committee meetings.

Introducing our new North American Major Accounts Manager
Doug Bigrigg
Sales veteran, Doug Bigrigg joins ViVitro Labs as North American Major Accounts Manager. He is responsible for engaging with our customers in North America including Heart Valve development, Heart Repair Device development and Heart Research within Academia.  

Doug brings over 20 years of sales experience. Most recently he was President and Owner of Argosy Communication Products providing international sales representation and distribution for a variety of two-way radio manufacturers.  

Doug's career includes extensive sales engineering experience in RF design and  radio communications as well as oceanographic instrumentation. Doug enjoys the outdoors, hiking, fishing and hockey.  He looks forward to meeting and helping North American clients and welcomes emails or phone calls. 

ViVitro at TCT 2015

Come visit us at TCT 2015 in booth # 1450. We will be featuring our updated Pulse Duplicator system with options for Mitral valves, QA / Production testing and our new flow meter.

If you would like to set up a time to meet during or after the show please email Gerry Wight.  Rob, Gerry, and Doug will be in attendance.

Dr. Othman Ahmed Ali Smadi, Assistant Professor of Mechanical Engineering, Department of Bio-Medical Engineering, The Hashemite University in Jordan, receives his certificate of training for ViVitro Labs SuperPump and Pulse Duplicator from Gerry Wight at ViVitro facilities in Victoria BC.
Interview: Muralidhar Padala on turning mechanisms of mitral valve disease into new technologies and solutions

Dr. Muralidhar Padala

Muralidhar Padala, Ph.D., is an Assistant Professor in the Division of Cardiothoracic Surgery at Emory University, and the Coulter Department of Biomedical Engineering at Georgia Institute of Technology in Atlanta. He directs the Structural Heart Disease Research and Innovation Lab focused on mitral valve disease and heart failure.

Rob Fraser, MSc., Lab Manager at ViVitro Labs, met Dr. Padala during a tour of the southeast US, was impressed with Dr. Padala’s work and use of the SuperPump in his research, and asked to share it with our readers. The following interview was conducted in late spring.



Joe McMahen conducts seminar in Beijing on August 25, covering ISO 5840-3:2013.

FAQ: 10 ways ViVitro Pulse Duplicator and HiCycle compare to equipment built in-house

By Rob Fraser

People often ask, “Why buy a ViVitro Pulse Duplicator or HiCycle when I could build something myself?  How do they compare to equipment built in-house?”

My initial reaction is always similar to that of Dominik Obrist: “It’s more complicated than you think.”  Dominik speaks from experience.

“Complicated” is actually short hand for “takes time, requires expertise, and ends up costing more.” 

Read Rob's top 10 list of reasons to purchase a Pulse Duplicator or Durability testing equipment.

Interview: Dominik Obrist on biomedical fluid dynamicist approach to determining mechanistic causes
Dr. Dominik Obrist 

Dr. Obrist is Professor for Cardiovascular Engineering at the ARTORG Center for Biomedical Engineering Research of the University Bern. His present research activities encompass several aspects of cardiovascular fluid mechanics (e.g. aortic valves, microcirculation) as well as other biomedical flow systems (e.g. gastric mixing, respiratory flow).

Dr. Obrist toured ViVitro Labs in Victoria recently. Lab Manager, Rob Fraser Msc., spoke with Dr. Obrist about his lab work in Bern, similarities in measuring different body fluid flows, and recent highlights.

Product Maintenance and Upgrades
ViVitro Labs offers 1 business day response to all service inquiries whether by email or phone for support or RMA return of failed products.

ViVitro Labs standard warranty is one (1) year and an extended warranty of up to five (5) additional years is available as a purchasable option.
Download data sheet

Europe, Africa and Israel Sales Representative

Karim MOUNEIMNE, PROTOMEDLABS SASU President & CEO and ViVitro Labs Europe, Africa and Israel product sales representative, visited ViVitro Labs in August for several days of training with the entire ViVitro team.  

The sessions were informative for everyone and Karim returned to France with the latest news and system updates.  Contact Karim.
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