Accelerated Wear Testing (AWT)
Study the durability (repeated opening and closing) of a heart valve prosthesis under accelerated conditions.
For devices which may experience an immediate total loss of function, testing is performed to a minimum of 400 million cycles. For devices with demonstrated gradual degradation function, testing is performed to a minimum of 200 million cycles. For devices without established clinical history or for submissions to certain regulatory bodies additional cycles may be required.
Specified differential pressure is maintained across the closed valve for 5 % or more of a single cycle. Using ViVitro’s expertise and equipment the maximum pressure across the valve is minimized to avoid over testing the device.
Samples experience full range of leaflet/occluder motion as measured under normotensive conditions under pulsatile flow. This determines the maximum speed at which a sample can run.
Devices shall be inspected (microscope, photographs, and high-speed video) and functionally evaluated under pulsatile flow at least every 50M cycles.
- ViVitro Labs HiCycle, or other Accelerated Durability Tester(s)
- Durability Pressure Data Acquisition System
- High speed video recording system
- 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
- 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
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
- Durability Testing (Integrated Durability Assessment)
- Dynamic Failure Mode (DFM)
- Real-Time Wear Testing (RWT)
- Pulsatile Flow Testing – Hydrodynamic Performance
- Scanning Electron Microscopy (SEM) and Optical Inspection
- Simulated Use Pre-conditioning
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. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.
ISO 17025 Accredited
For studies used for regulatory approval this is a must. Victoria and Marseille labs accredited by A2LA.
Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.
We happily provide Non-Disclosure Agreements for all services, including initial consultation.