Medical Device Testing Services
Medical Device Testing
Dynatek Labs, Inc. is a global leader in innovative heart valve, vascular stent, vascular prosthesis, custom device, and Humanitarian Use Device (HUD) testing, offering world-class competencies in testing services for medical device companies.
Heart Valve Testing
Dynatek can test all percutaneously-delivered heart valves. We also test septal defect closure devices, artificial heart bladders, membranes/sheets, sutures/clips and intra-aortic balloons on the M6 Heart Valve Tester.
Stent Durability Testing
Radial pulsatile durability testing is performed in our contract testing lab on one of several proprietary test platforms listed above, to evaluate the long-term mechanical integrity of the stent or stent graft under pulsatile cyclic loading conditions.
Coating Durability Testing
When a stent or stent graft is tested on the patented CDT-5 or CDT-20, it is tested for both pulsatile durability and coating durability simultaneously.
Acute Particulate Testing of Stents and Catheters
Dynatek’s patented Acute Particulate Tester leverages its world class particulate analysis technology for acute applications. ASTM and ISO regulations drive the acute phase particulate testing of medical devices destined for use in the human vasculature.
Stent Bend Testing
Dynatek Labs offers testing to replicate radial and non-radial forces of other anatomical locations, including the renal artery, superficial femoral artery, popliteal artery, and axillary artery.
ISO/AAMI recommends two methods for the analysis of particulates shed by vascular stents and stent-grafts, balloons and delivery catheters in liquids:
i. Light obscuration, and
ii. Microscopic analysis
High Speed Photographic Verification of Stent Deflection
A high speed photographic camera was used to determine the distension of the stent within the mock vessel. The camera’s associated software has the capability of analyzing the fast motion within the captured image.