Durability Testing (Integrated Durability Assessment)

Durability testing is intended to determine the in-vitro lifetime, the anticipated failure modes, and  potential failure consequences (e.g. immediate total loss of  function or gradual degradation of  function).

Durability testing investigates the interaction between of various components of a finished medical device.

Test Procedure

Due to the complexity of the devices and experimental setups, and the long test duration, a combination of approaches such as Accelerated Wear Testing (AWT), Dynamic Failure Mode Testing (DFM), and  Real-time wear testing (RWT) may be employed.

Equipment

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 ViVitro AWT System with Dual Control Technology (DCT)™ and the ViVitro Real Time Wear Testing System offer customization to accommodate a wide variety of cardiovascular devices.

The ViVitro AWT System with Dual Control Technology (DCT)™ minimizes the probability of test artifacts resulting in false negative events during Accelerated Wear Testing, and avoid costly R&D iterations on perfectly sound designs of heart valve prosthesis, occluders, closure devices, patches, valvular repair or reconstruction devices.
The ViVitro Real Time Wear Testing (RWT) System was built with customization in mind. Custom fixturing is mounted inside a temperature controlled tank and subjected to loading via bellows and the SuperPump.

Measured Parameters

  • Number of Cycles conforming to loading conditions (target pressures across the closed valve were attained for at least 5 % of each cycle)
  • Sample pressure waveforms
  • Opening and closing kinematics under highspeed video
  • Photographic documentation of the appearance of the test sample at defined inspection intervals
  • Hydrodynamic performance at defined inspection intervals

Scope

  • Surgical Valves: SAVR, SMVR, SPVR, STVR
  • Transcatheter Valves: TAVI / TAVR, TMVI / TMVR, TPVI / TPVRTMVR, TTVR / TTVI  and any other transcatheter valve
  • Biological, Polymeric, mechanical valves, tissue engineered
  • Artificial heart valves prosthesis
  • Venous valves
  • Valvular conduits
  • Any valvular prosthesis
  • Any cardiac repair device

Service Levels

Applicable Standards

  • ISO 5840-2:2021
    Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

  • ISO 5840-3:2021
    Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques

Related Tests

QV-502, OLE0909

ViVitro Labs Heart Valve Durability Tester with ADC™ technology

ViVitro Labs Heart Valve Durability Tester with ADC™ technology


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:

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Victoria and Marseille labs accredited by A2LA.

Test Method Validation
The FDA and Notified Bodies around the world are requiring evidence of Test Method Validation. ViVitro Labs has invested significant resources to validate the most common test methods that are not ISO 17025 accredited. We continue to work closely with device manufacturers and share the burden with our clients to validate other specific test methods that are less in demand.

Timeliness
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.

Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.

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

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