Acute Particulate Testing of Vascular Devices

Particle Counting

Dynatek’s patented¹ 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. Acute Particulate Testing of vascular devices such as stents, stent-grafts, balloons, occluders, and delivery systems includes:

1. Particulate Matter Evaluation during Deployment and Withdrawal

2. Coating Integrity Inspection

Dynatek Labs provides a ‘one stop’ facility for your Acute Particulate Testing requirements.

1 US Patent # 9,453,788 B2

Particulate Matter Evaluation

FDA recommends that the device manufacturer is able to “demonstrate that the delivery catheter can safely and reliably deliver the stent to the intended location and that the stent is not adversely affected by the delivery catheter, both during deployment and withdrawal.”

Dynatek’s innovative Acute Particulate Testing platform includes a closed, temperature-controlled loop into which the vascular device is deployed, allowing the user to monitor particle shedding behavior in real time.

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. 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 virtual bins.

Downstream of the particle counters, the particles are captured by optional particle capture filters, for SEM/EDX/FTIR analysis giving you critical information about the composition of the shed particles.

Dynatek can also have your stent or other device analyzed with SEM, furnishing you with SEM images that show the surface characteristics of the device both before and after acute particulate testing, as required by FDA regulations.

Clients may choose to perform this test at Dynatek’s testing lab; alternatively, Dynatek scientists can perform sample deployments, based on your protocol.

Coating Integrity Inspection

Coating Integrity Inspection is normally carried out by an optical microscope or a scanning electron microscope under appropriate magnification. The stent is inspected before expansion, after expansion to its nominal or maximum diameter and after simulated use. Coating integrity inspection is performed to determine delamination or degradation of a vascular device during deployment. An affiliate lab performs all SEM coating integrity inspections for Dynatek customers, including a detailed report with images of defects, anomalies and artifacts found on the device surface.

Coating integrity inspection may organize coating defects and anomalies into several categories:

Category I – Anomalies related to coating thickness, which may be due to increased or decreased coating at any given point on the stent surface. Such anomalies may result in the exposure of bare metal in some areas or the formation of cracks, especially on the inside of curves or cause ‘blisters’ or ridges in the coating material

Category II – Non-homogenous coating may result in ‘wrinkle’ formation or ‘crater’ formation with or without metal exposure

Category III – Coating displacement may result in anomalies such as ‘webbing’ that may occur with or without metal exposure

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