Medical Device Testing Services

Stent deployment

Testing Services

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.

M6 Heart Valve Tester

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.

SVP Stent 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.

Acute Particulate Testing of Stents and Catheters

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

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.

bend testing

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.

SEM Analysis of Particles

SEM Service

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

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.

Dynatek Labs, Inc.
105 East 4th Street
Galena, MO 65656
417.357.6155
800.325.8252
fax 417.357.6327