Real-Time Wear Testing (RWT)
Real-time wear testing (RWT) is intended to match physiological loading conditions as closely as possible as to what would be obtained in a real patient. Due to the viscoelastic nature of some materials, Accelerated Wear Testing may actually under test devices, so RWT can be used to identify frequency dependent failure modes.
Testing durations of 50 million cycles or greater will be performed.
Testing at physiologic conditions (beat rates < 200 BPM).
The target differential pressure shall be maintained across the closed valve for 20 % of the cycle.
A detailed description of valve appearance (photographs and videos) along with hydrodynamic functional evaluations shall be made at 0, 25, and 50 millions cycles. These results should be compared to results achieved during Accelerated Wear Testing (AWT). Note this may require an additional inspection point during AWT at 25 million cycles, as this is not typically performed.
- ViVitro Labs Real Time Wear Tester
- 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
- Critical for viscoelastic materials
- Required for devices without established clinical history
- Recommended for devices which may not survive the severe loading typically imparted by accelerated testing
- 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 1: General requirements
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
Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
- Durability Testing (Integrated Durability Assessment)
- Accelerated Wear Testing (AWT)
- Dynamic Failure Mode (DFM)
- 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.
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.