Dynatek Laboratories has recently completed testing of carotid artery stents in a tester custom-designed to replicate the motion of the carotid artery during head turning
In addition, testing of renal artery stents is currently underway in testers designed to replicate the bending of the renal artery during respiration.
Both tests are performed to evaluate the integrity of the stents under non-radial fatigue, and data obtained from the tests will be used for FDA submission.
In addition to renal and carotid artery devices, Dynatek Laboratories offers testing to replicate radial and non-radial forces of other anatomical locations, including the superficial femoral artery, popliteal artery, and axillary artery.
Failure of vascular stents due to non-radial biomechanical forces, including bending of the artery, is well documented, and may lead to occlusion of the artery.
Evaluation of a stent's ability to withstand these forces is an important step in determining the safety of the stent.
In addition, this type of bend testing is recommended by the FDA in its Guidance for Industry and FDA Staff, and is included in draft standards of AAMI.
Dynatek Laboratories is active in accelerated in vitro testing of cardiovascular devices, with over 20 years experience.
When the need for in vitro testing of vascular stents arose, Dynatek met the need by offering the first stent testing in a dynamic, pulsatile environment.
Having performed testing for many of the largest and smallest of companies, we are equipped to meet the testing needs of each individual client.
As changes have occurred in stent materials, designs, locations of deployment, and standards for testing, and as more data has been collected concerning failure modes in vivo, Dynatek has modified its capabilities to address these changes.
