BDC Laboratories designed the RDT-7600i pulsatile durability test system to reduce the time engineers spend setting up, monitoring, and adjusting long-running endovascular implant studies. Now that we are using the system in our own testing lab, we’re seeing those efficiency gains firsthand.
Pulsatile, or radial, durability testing of endovascular implants is inherently time-consuming. A typical study requires 400 million cycles to simulate approximately 10 years of use, which can take anywhere from three months to a year. Throughout that time, the test system must maintain precise diametric strain conditions to meet ASTM F2477-23 standards, placing heavy demands on the engineers and technicians who monitor and adjust radial fatigue and durability tests.
After years of conducting these studies with our previous systems, the difference with the RDT-7600i is clear. We are seeing meaningful time savings in three key areas.
Setting up a study on all other pulsatile durability test systems typically takes the majority of one week. With the RDT-7600i, we have reduced that process to about two days.
Each of the RDT-7600i’s six stations operates independently, allowing operators to mount, fill, and de-air samples individually. The angled station design reduces de-airing from hours, or potentially a day, to only minutes. These individually controlled stations also allow users to conduct multiple studies on a single system, since different pressures, frequencies, and motor strokes can be applied on each station.
In addition, the test system’s integrated optical measurement and automated characterization replace many of the manual positioning and data-collection steps previously required during setup.
Interim inspections that previously required the better part of a day can now typically be completed in under two hours. The RDT-7600i achieves these efficiency gains by automating condition monitoring and making precise adjustments throughout a study.
The RDT-7600i measures conditions and makes automatic adjustments station by station throughout a study, rather than manual system-wide adjustments as with all other commercial test systems. This results in more precise test control and reduces the likelihood of overstraining samples beyond clinically relevant conditions.
Because the RDT-7600i can check and adjust conditions at much shorter intervals – every 1 million cycles instead of every 25 million, for example – it substantially reduces the risk of losing weeks, or even months, of testing progress due to having to repeat cycles for being out of tolerance.
Independent station control also changes how operators manage unexpected events, such as sample or mock vessel failure. When an event occurs, operators can stop and address that individual station while the remaining samples continue cycling. A problem that could previously stop an entire study for a full day can now be resolved on a single station within one to two hours.
These efficiencies do not change the rigor or accuracy of the test results. They provide a faster, more automated, and more flexible way to produce the precise data medical device developers and regulatory authorities need to confirm a technology’s safety.
We’re offering a complimentary 30-day test for companies interested in seeing the RDT-7600i in action. You can visit our laboratory to review the setup firsthand or send us your device for evaluation.
Contact us to get started.