Acute Particulate Testing of Stents and Catheters
Acute Particulate Testing of Stents and Catheters
(US Patent # 9,453,788 B2)
ASTM and ISO regulations drive the acute phase testing of stents and catheters from the particulate shedding perspective. Dynatek has leveraged its world-class particle-counting technology for assessing the particle-shedding behavior of these vascular devices.
Dynatek’s innovative patented acute phase test platform includes a closed, temperature-controlled loop into which the test stent or catheter is deployed.
The vascular device is moved down this loop until it reaches the tortuous path, a section of the test tracking fixture that is described in ASTM F2394-07, or alternatively, a tortuous path furnished by the client. Dynatek has a highly capable vendor who can fabricate such tortuous paths easily for you. Particles shed by the device as it navigates the tortuous path flow directly into a debubbler and then through custom laser-based particle counters that both count and size particles into user-defined bins.
Downstream of the particle counters, the particles are captured by optional particle capture filters, for SEM/EDX analysis by Dynatek’s SEM vendor or by the client at their own facilities, giving you critical information about the composition of the shed particles.
Dynatek can also have your stent analyzed visually under SEM, and furnish you with SEM images that show the surface characteristics of your device both before and after acute phase testing, as required by FDA regulations. Dynatek can perform sample deployments in the Acute Phase Tester, based on your protocol.
Acute Particulate Testing page
Acute Particulate Tester product page
Dynatek Labs, Inc.
105 East 4th Street
Galena, MO 65656
417.357.6155
800.325.8252
fax 417.357.6327
