Test at accelerated speeds? Yes!
Test at physiological speeds? Yes!
Test at high temperatures and expanded pH levels? Yes!
Verify stent deflection using high speed photography? Yes!
ISO, ASTM and FDA regulations require the testing of stents and stent grafts for at least 380 million cycles. At physiological speeds of 72 beats per minute (1.2 Hz), it would take one month for 3.1 million cycles of testing, or literally 10 years to meet the regulatory requirements. To meet the regulatory requirements of 380 million cycles, regulatory agencies allow testing at accelerated speeds, leading to shorter test periods, and significantly lower testing costs.
Dynatek offers accelerated and physiological testing on our SVP-24/UST Universal Stent Tester, the CDT-5 Coating Durability Tester and the CDT-20 Coating Durability Tester.
Dynatek’s testers feature proprietary Hyper Drive motors that are capable of over 60 Hz or 3,600 rpm, far in excess of physiological conditions. Assuming the intravascular device can tolerate such speeds, 380 million cycles can be completed in 10 weeks!
Dynatek can assist you in developing a test protocol that will offer you the fastest possible speed for accelerated durability testing of stents, stent grafts and intravascular devices.
In addition to accelerated speeds, some customers have chosen to test at higher temperatures and expanded pH levels, as part of their test-to-failure protocols. Contact us to find out more about such testing protocols.
Verification of stent deflection using high speed photography is the most accurate way to measure deflection. Dynatek routinely performs accelerated durability testing of intravascular devices using high speed photography.
No one tests faster than we do!