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
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.
- Learn more
- The Comprehensive Validation of a Stent Coating Durability Tester
- A Comprehensive Protocol and Procedural Considerations Designed …
- Particle Counters for Stent Testers
- SEM Analysis of Particles
- Compliant Silicone Vessels
- High Speed Photographic Verification of Stent Deflection
- Particulate Capture from Vascular Stents
- UC3-HD Controller
- Testing Standards relevant to the CDT-5
- ISO 12417-1:2015
- ISO/TS 17137:2014
- ASTM F2743-11
- ASTM F3036-13
- ASTM F2477-07
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.
Dynatek Labs Model CDT-5 Product Specification
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Description
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Specifications
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Additional Information
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|---|---|---|
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Number of test samples
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5 test samples
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Mock vessel configuration
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Straight, curved, or bifurcated
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Additional special configurations upon request |
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Mock vessel length (straight)
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Adjustable to ≤ 250 mm
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Mock vessel inner diameter
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≈1.5 mm to ≤ 10 mm
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Typical mock vessel compliance
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5% to 7% per 100 mmHg | Other specifications available upon request |
| Testing rate |
1.2 to 150Hz
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Testing fluid
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PBS or distilled water
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Other testing solutions possible |
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Fluid temperature
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Ambient to ≤ 45⁰C
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Flow rate
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100 mL/min per sample
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| Test control parameters | Stent deflection (with high speed camera), Tube deflection (with laser micrometer), Tube pressure (with pressure transducer) |
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Laser micrometer
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Solid-state laser diode (optional; 780 nm) | |
| Pressure transducer range | 0-10 psig | |
| System fluid filter | 0.2 micron | |
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Particle capture filters
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5 (optional) | 1 common or 5 individual |
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Particle capture pore size
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5 micron (optional, other pore sizes available) | |
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Controller
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Universal Controller, featuring the NI™ Single-Board RIO platform | |
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Software
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Dynatek DAQ software based on LabVIEW architecture | |
| Capacitance tank | 1.5 gal |
Particle Counter Specifications
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Description
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Specifications
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Additional Information
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|---|---|---|
| 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 |
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Particle counter calibration standard
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USP <788>, ASTM F658 | |
| Sizing resolution | 5-50 micron: +/- 1 micron 50-100 micron: +/- 5 micron |
Dimensions and Power Requirements
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Module
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Dimensions
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Power Requirement
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Weight
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|---|---|---|---|
| CDT-5 (base unit) | 14 ¾” W X 20”D X 55”H |
120 VAC 5.0 A
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95 lbs
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Dynatek Labs, Inc.
105 East 4th Street
Galena, MO 65656
417.357.6155
800.325.8252
fax 417.357.6327
