CDT-5 Particle Counting Stent Tester

 Stent Particle Testing

      

CDT-5: The affordable durability tester for coated stents

The modular design of the patented1 CDT-5 Coating Durability Tester from Dynatek Labs, Inc. offers durability testing and real-time particle counts from coated and bare metal stents in a compact footprint. The CDT-5 is an affordable durability tester for up to five stent samples in straight, curved or bifurcated mock vessels, with the capability to count particles being shed by these stents in real time. The CDT-5’s linear motor produces an adjustable bellows compression which allows for stent loading conditions from physiological to accelerated testing rates of up to 150Hz. Samples can be tested at precisely controlled test parameters, and samples are easily accessed at all times for visual inspection or high speed photography. Ideally suited for screening sample candidates in early stage stent research, the CDT-5 offers unmatched flexibility. By allowing you to upgrade with an optional laser micrometer and optional particle-capturing filters, the CDT-5 offers you the same technology as the workhorse CDT-20, Dynatek’s 20-sample Coating Durability Tester, but with a significantly lower upfront investment. This machine has a master file located at the USFDA.

1 US Patent # 7,621,192 B2

Stent Particle Testing
Stent Particle Testing

The perfect low-to-medium throughput platform

The CDT-5 features the technology of the CDT-20 while meeting the need for a low-to-medium throughput. For young companies looking to rapidly screen stent candidates, or established labs validating new stent designs, the CDT-5 provides the most cost-effective solution. Dynatek knows what’s important to you: affordability, flexibility and cutting-edge science and engineering. With the CDT-5, you get them all.

Validate your stent design easily

The CDT-5 allows you to count particles in real time, as they are being shed by your stents. The particle counter detects and logs particle size and quantity, displaying the counts on screen. Real time particle counting is a critical tool in your stent design toolbox, helping you understand your stent’s particle-shedding behavior.

Tremendous flexibility in a modular system

Dynatek’s CDT-5 was designed from the ground up to be a modular system that can be upgraded to keep pace with your testing needs. Up to five straight, curved or bifurcated tube configurations can be tested under physiological to accelerated conditions produced by compressible bellows driven by our proven linear motor. Designed to support your lab’s current and future demands, the CDT-5’s modular system allows for an upgrade with an optional laser micrometer for accurate measurements of tube deflection. Looking to characterize particles shed by your stent? The CDT-5 can also be upgraded with an optional system that features an individual filter for every tubing sample, allowing you to capture particles shed by each stent in real time.

 

Dedicated software gets you results faster

The CDT-5’s software package is easy to use right out of the box. Intuitive menus with large, easy-to-read ‘dial type’ readouts on screen allow you to conveniently set up, monitor and control instrument status. Data from your tests are logged into TDMS files that can be accessed by Excel, DIAdem and Matlab programs.

Unmatched support provides peace of mind

The technology, quality and reliability of our instruments have made Dynatek the undisputed world leader in durability testing. When you invest in the CDT-5, our world-class support is included, from training your staff to ensuring maximum instrument uptime.

 

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
ASTM Link

Standard Guide for Testing Absorbable Stents
ASTM Link

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

True deflection metrics – in real time

An optional laser micrometer on the CDT-5 monitors the realtime outer diameter of the selected mock vessel as it undergoes deflection. However, we know seeing is believing, and for the most accurate visualization of stent deflection, we recommend the optional high-speed camera. Two user-chosen points on the stent are mapped throughout each cycle resulting in a very accurate determination of stent deflection. With this tester, you will be compliant with the requirements of upcoming regulations that mandate observation of actual stent deflection. Only the CDT-5 and its sibling the CDT-20 Coating Durability Testers offer the optional high-speed camera upgrade.

Cutting-edge science with convenient operation

The CDT-5 offers a powerful solution to stent testing challenges, while remaining an easy instrument to operate. Case in point: you can hot-swap samples on the CDT-5 in minutes with the optional isolation valve system and spike wrench. Dynatek believes that powerful technology should be easy to use and the CDT-5 exemplifies this belief.

Stent Testing
Now includes newly designed controller.
Particle Counting
Now includes newly designed particle counter.

Dynatek Labs Model CDT-5 Product Specification

Description
Specifications
Additional Information
Number of test samples
5 test samples
Mock vessel configuration
Straight, curved, or bifurcated
Additional special configurations upon request
Mock vessel length (straight)
Adjustable to ≤ 250 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 150Hz
Testing fluid
PBS or distilled water
 Other testing solutions possible
Fluid temperature
Ambient to ≤ 45⁰C
Flow rate
100 mL/min per sample
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
5 (optional)  1 common or 5 individual
Particle capture pore size
5 micron (optional, other pore sizes available)
Controller
Universal Controller, featuring the NI™ Single-Board RIO platform
Software
Dynatek DAQ software based on LabVIEW architecture
Capacitance tank 1.5 gal

Particle Counter Specifications

Description
Specifications
Additional Information
Number of particle counter modules 5 Individual modules for each sample lane
Particle size range 5-900 micron Size and count up to 100 micron
Count up to 900 micron
Max. particle concentration 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

Module
Dimensions
Power Requirement
Weight
CDT-5 (base unit) 14 ¾” W X 20”D X 55”H
120 VAC 5.0 A
95 lbs

 

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

Dynatek Labs