CDT-20 Particle Counting Stent Tester

Stent Particle Testing


Dynatek’s patented1 Coating Durability Tester utilizes a Hyper Drive linear motor to produce an adjustable bellows compression which allows for physiologically relevant stent loading conditions for up to 20 test samples from physiological to accelerated testing rates of up to 150Hz.

Dynatek’s laser particle detection system allows accurate real-time counting, sizing, and data logging of shed particles from each drug-eluting stent during testing, giving a time course of shed particulates from each sample.

The large number of samples greatly benefits manufacturing QA when ongoing testing of approved stents is required.

CDT-20 Features and Capabilities

  • FDA accepted with appropriate documentation.
  • A master file on the machine is located at the USFDA.
  • Compact integrated mounting stand or benchtop configurations available.
  • Ability to test up to 20 samples simultaneously under precisely controlled test parameters.2
  • Ability to test samples of slightly varying sizes of the same design at the same precisely controlled test parameters.
  • Patented* system used to detect and identify, in real time, the number and size of shed particles from each sample.
  • Integrated system has a smaller footprint than previous systems.
  • Advanced universal controller with unmatched data collection ability.
  • Data logging to a TDMS file which can be accessed by Excel or other software such as DIAdem and Matlab, for managing, analyzing, and reporting the test data collected.
  • Unique redundant filtration system that allows for filter changes without test interruption.
  • Frequency, temperature, and pressure controls give the user the ability to establish, maintain, and recall required test parameters.
  • Ability to monitor sample tube pressures at all test frequencies.
  • Closed loop laser micrometer feedback allows for automatic control and monitoring of mock artery distension.
  • Long life electromagnetic Hyper Drive linear motor.
  • Design allows for easy access to test samples.
  • Universal controller allows for future expansion of the CDT-20 system to accommodate future host computer technology.
  • Future upgrades with advance SCADA technology allow complete lab monitoring of all machines from a single host computer.

1US Patent # 7,621,192 B2
2Number of test samples dependent on diameter and compliance of sample tubes.

Stent Particle Testing
Stent Particle Testing

Available Add-ons

  • Individual filters for each test sample.
  • Various diameters of graft tube adapters for different test sample sizes.
  • Custom modifications for the rack mount system.
  • Valves to allow individual samples to be removed or replaced without interrupting the test.
  • Very large diameter test samples possible with custom hardware.
  • Alternative cap tanks and fluid heaters for higher test temperatures.
  • UPS (Uninterruptable Power Supply) system.
  • Adapters for catheter deployment of stents on the tester.
  • Custom particle counter calibration for atypical particle size ranges.
  • Custom collection filters available to aid in chemical analysis of particles.
  • Other custom modifications at customer request.
Stent Particle Testing

Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
ISO Link

Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
ISO Link

Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems

Standard Guide for Testing Absorbable Stents

Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

Dynatek Labs Model CDT-20 Product Specifications

Additional Information
Number of test samples
20 test samples
20 test samples standard
Mock vessel configuration
Straight, curved, or bifurcated
Additional special configurations upon request
Mock vessel length (straight)
to ≤ 254 mm
Mock vessel inner diameter
≈1.5 mm to ≤ 10 mm
Typical mock vessel compliance
5% to 7% per 100 mmHg
Other specifications available upon request
Testing rate
1.2 to 150 Hz
Testing fluid
PBS or distilled water
Other testing solutions possible
Fluid temperature
Ambient to ≤ 45⁰C
Flow rate
100 mL/min per sample
Per Lane
Test control parameters
Stent deflection (with high speed camera),
Tube deflection (with laser micrometer),
Tube pressure (with pressure transducer)
Laser micrometer
Solid-state laser diode (optional; 780 nm)
Pressure transducer range
0-10 psig
System fluid filter
0.2 micron
Particle capture filters
20 (optional)
1 common or up to 20 individual
Particle capture pore size
5 micron (optional)
Other pore sizes available
Universal Controller, featuring the NI™ Single-Board RIO platform
Dynatek DAQ software based on LabVIEW architecture
Capacitance tank
1.5 gal

Dynatek Labs Model Particle Counter Specifications

Additional Information
Number of particle counter modules
Individual modules for each sample lane
Particle size range 5-900 micron Size and count up to 100 micron
Count up to 900 micron
Particle count range 15,000 p/mL @ 10 micron
Particle bin range 2-6 bins 5 bins of 5-100 micron
1 bin for 100-900 micron
Particle counter calibration standard
USP <788>, ASTM F658
Sizing resolution  5-50 micron: +/- 1 micron
50-100 micron: +/- 5 micron

Dimensions and Power Requirements

Power Requirement
CDT-20 Integrated system
38”W x 40”D
x 94”H
120 VAC 12 A
745 lbs.
(complete system)
CDT-20 Bench Top system
60”W x 72”D
x 53”H
120 VAC 12 A
600 lbs.
(complete system)

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

Dynatek Labs