Share on FacebookTweet about this on TwitterShare on LinkedIn

Services » Durability Testing

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.

Outsource your durability tests to ViVitro experts:

  • Decrease time to market
  • Lower capital expenses
  • Increase sample size flexibility

High speed videography and daily visual inspections provide feedback and peace of mind throughout the process.

Our extensive knowledge of the ISO 5840 standard ensures test protocols will always meet regulatory approval. Detailed reports identify whether devices pass or fail ISO 5840 requirements and provide the information needed to make informed decisions about the device design.

Valves (Transcatheter, Biological, Mechanical, Venous, Conduits)

Durability Testing (ISO 5840-3:2013 Annex O, ISO 5840-2:2015 Annex G)

ViVitro Labs personnel participate on the ISO 5840 standard committee to ensure test protocols always meet regulatory requirements. Detailed reports advise device pass/fail status for ISO 5840 and provide information needed to make device design corrective decisions.

Unless the labeling for a particular device includes an explicit statement about anticipated in vivo device lifetime, testing is performed to ensure rigid heart valve substitutes will remain functional for 400 million cycles and that flexible heart valve substitutes will remain functional for 200 million cycles as per ISO 5840 requirements. Depending on valve kinematics, a typical test is conducted at 700-800 BPM, however, the HiCycle is capable of speeds up to 1650 BPM. At these rates a device can be cycled through approximately 1 million cycles per day.

For regulatory submission testing devices have to meet final design and manufacturing specifications. Each valve will be subjected to the maximum recommended number of sterilization cycles, process chemicals, aging effects, and any catheter loading and deployment steps (including repositioning and recapturing if applicable). This ensures that tests are performed on representative samples.

Regulatory submission also requires comparing the damage observed in the test valves with that observed in an equivalent reference valve with known clinical data. The test must also have a priori defined pass/fail criteria for structural and functional failure based on a risk assessment. Examples of structural deterioration include holes, tears, gross delamination, fraying, incomplete coaptation, fracture, excessive deformation, failure of any individual component, other mechanical breakdown and/or wear. Examples of functional impairment include excessive regurgitation and/or excessive transvalvular forward flow pressure difference based on the minimum performance requirements specified in ISO 5840.

A detailed description of the heart valve substitutes and hydrodynamic performance must be conducted prior to the test, at the completion of the test, and at least every 50 million cycles during the test. We use high resolution photography, microscopy (including SEM if required) and high speed videography to capture wear on heart valve substitutes. We also use the ViVitro Labs pulse duplicator to conduct hydrodynamic assessments throughout the test to determine if valves are meeting acceptance criteria.

Dynamic Failure Mode (ISO 5840-3:2013 Annex O.6, ISO 5840-2:2015 Annex G.4)

The potential failure modes of devices associated with structure deterioration should be identified and well understood. For feasibility purposes this can be testing a sample until failure or for submission to a regulatory body this test is often performed after a device has successfully survived the target lifetime. Often times to obtain results more quickly this test can be made more severe by increasing the cycling rate and/or loading on a device.

Real Time Wear Testing (ISO 5840-3:2013 Annex O.5, ISO 5840-2:20015 Annex G.3)

In addition to accelerated wear testing, testing at physiologic conditions (beat rates < 200 BPM) on the ViVitro Labs Real Time Wear Tester may also be useful in characterizing the wear on devices. Similar to a chronic animal study, this test shows how a device will perform under physiological loading.  It is recommended for devices which may not survive the severe loading typically imparted by accelerated testing.

 

Cardiovascular Devices

As manufacturer of the world’s leading durability test instruments, ViVitro Labs is well equipped to offer durability testing to a wide range of cardiac devices. The HiCycle and Real Time Wear Tester offer customization to accommodate a wide variety of cardiovascular devices.

  • The HiCycle moves a test sample through a static column of fluid and is ideal for occluders, closure devices, patches, valvular repair or reconstruction devices.
  • The RWT was built with customization in mind. Custom fixturing is mounted inside a temperature controlled tank and subjected to loading via bellows and the SuperPump.

 

Contact us today to discuss your cardiovascular testing needs including:

  • Ventricular Assist devices (VAD, LVAD, RVAD) (ISO 14708-5:2010 Annex DD)
  • Total artificial hearts (TAH) (ISO 14708-5:2010 Annex DD)
  • Occluders or Closure Devices (ASD – Atrial Septal Defect, PFO – Patent Foramen Ovale, ASO – Atrial Septal Occluder, VSD- Ventricular Septal Defect, PDA Patent Ductus Arteriosus, PLD- Paravalvular Leakage Device)
  • Valvular repair or reconstruction devices
  • Shunts
  • Stents
  • Delivery systems
  • Intra-aortic balloon pumps

_Q7A3925

Testing Outputs:

  • Well documented operating conditions and resulting device performance
  • Assessment of Pass/Fail criteria if applicable
  • High-speed videography and daily visual inspections for feedback and peace of mind throughout the process
  • High resolution photography and microscopy (including SEM) for wear characterization

HiCycles for Durability Testing
download-brochure

 
 

Flow-Induced Calcification Service:

Joe and RobF in lab

Calcification testing is available for cardiovascular devices including prosthetic valves and conduits and other cardiovascular devices that contain tissue, or may be susceptible to calcification. Download Calcification brochure.

Demonstrate effectiveness of anti-calcification treatment

The degree of calcification can be quantified using μCT, Spectroscopy, or histology (Von Kossa staining) upon request.

The volume and location of calcium deposits can be determined with μCT. This test can give bulk distribution throughout the valve, or highlight calcium deposit through the thickness of the
tissue depending on the resolution selected.

As a valve calcifies it also becomes increasingly stenotic. Increased gradients across the valve can be characterized by ViVitro with hydrodynamic testing before and after calcification.

 

ViVitro Labs Advantages

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.

Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.

STAY UPDATED

Sign up for our newsletter today