CDT-20
Introducing:
The world’s first
high-throughput
real-time
particle counter
for stents.
Coating Durability Tester
Discover what you’ve not been seeing with your stents
CDT-20: The most powerful coating durability tester in the world
Introducing the patented1 CDT-20 Coating Durability Tester from Dynatek Labs. Inc., the world’s first
and only high-throughput stent tester offering durability testing and real-time particle counts from
coated and bare metal stents. Capable of testing 20 coated or bare stents of similar sizes2 for durability
simultaneously, the CDT-20 is a powerful workhorse that can drive your stent from the lab to regulatory
approval in record time. An optional isolation valve system allows you to hot-swap samples in minutes.
Deployment phase data can be obtained using an optional Tuohy-Borst fitting for stent delivery. Data
from your tests are encrypted for security and logged into TDMS files that can be accessed by Excel,
DIAdem and Matlab programs.
High-throughput testing speeds you to
regulatory approval
The CDT-20 features Dynatek’s Hyper Drive linear motor to produce
an adjustable bellows compression which allows for physiological
to accelerated loading conditions for up to 20 stent samples
simultaneously. Unrivaled flexibility allows you to test straight, curved
or bifurcated tube configurations under precisely controlled test
parameters, while tube deflection is monitored by a laser micrometer3.
The CDT-20 is available in two configurations: benchtop or with an
integrated mounting stand.
Particle counts track shedding behavior of
stents
Particle shedding by coated and bare metal stents is a regulatory
concern, but it doesn’t need to be yours – with the CDT-20. With
cutting-edge patented technology, the CDT-20 features 20 customdesigned laser particle counters that detect, in real time, the number
and size of particles greater than 5 microns4 shed by each individual
stent during pulsatile durability testing. Once these particles are
detected, they are categorized into between 2-6 configurable size
ranges or virtual ‘bins.’
Real time counts offer powerful insight into
potential disease state formation
Instead of a single count of all shed particles after a test run is
completed, the CDT-20 allows you to count particles as they are being
shed. As particles pass through the particle counter, they are detected
and logged by particle size and quantity. Real time counts let you
visualize when and how much your stent is shedding particles at every
stage of testing, helping you understand your stent’s potential for
promoting a pathological condition in vivo.
Dynatek’s CDT-20 benchtop Coating Durability Tester
Real time particle counts on the CDT-20
“…the CDT-20 takes us beyond compliance
to true patient safety by allowing us to
address standards passed or being drafted
by the ASTM and AAMI/ISO committees that
focus on the release of particulates from
stents…”
Designed to take your product beyond regulatory compliance to real patient safety
Particle characterization drives stent
design
An optional filtration system for the CDT-20 is available, featuring
a separate filter for each stent sample. The particles shed by
each stent are captured by individual downstream filters, allowing
you to chemically characterize them. Chemical characterization
of particles sheds light on potential toxicity and provides vital
information that affects coating and stent design.
“…if you’re not counting particles in real time,
you’re not getting the full picture…”
25 micron particle on a 10 micron filter membrane
Deflection monitoring that exceeds
current regulatory standards
Real time high-speed photography showing two points on stent
being tracked
“You guys are always easy to contact and
provide the best customer support ever; truly
appreciate it!”
Easy to use walk-up operation
It has never been simpler to get advanced technology into your
stent testing lab. The unrivaled technology offered by the CDT-20
is matched by its easy-to-use walk-up operation. Everything in the
CDT-20 has been designed to flatten the learning curve of its users,
ensuring that your path to reliable, consistent results is short and
smooth.
Count on us for world-class support
The CDT-20 can monitor the tube deflection of up to 20 stents
serially with a laser micrometer that actively measures the realtime outer diameter of the selected mock artery as it undergoes
deflection. For the most accurate picture of stent deflection,
however, we recommend the optional high-speed camera. The
high-speed camera tracks two digital points on the stent and the
relative distance between the markings will change as the mock
vessel hosting the stent expands and contracts, providing critical
stent deflection data. With the CDT-20, you will be compliant with
the requirement of upcoming regulations that mandate observation
of actual stent deflection.
With Dynatek, your investment in cutting-edge technology comes
complete with peace of mind. Our comprehensive support services
for instruments are designed to ensure continuous uptime of your
testing platform. When you choose the CDT-20, you receive the
high-quality service that Dynatek has been known to deliver for
decades.
Dynatek’s CDT-20 Coating Durability Tester Specications
Description Specification
Number of test samples 20
Tube configuration Straight, curved or bifurcated
Tube length (straight) Adjustable to ≤220 mm
Tube inner diameter ≈1 mm to ≤15 mm
Typical distention 0.3% to 18% of tube ID
Testing fluid PBS or distilled water
Fluid temperature Ambient to ≤45º
Flow rate 100 mL/min per sample
Test parameters Stent deflection, tube deflection, pressure, temperature, frequency
Automatic test control method Tube distention
Pressure transducer 0-10 psig
Laser micrometer Solid-state laser diode (780 nm, 3 mW)
Number of particle counters 20
Particle size range 5-1,000 microns
Max. particle concentration 15,000 p/mL @ 10 microns
Particle bin range 2-6 bins
System fluid filter 0.2 micron
Particle capture filters 20 (optional)
Particle capture filter size 1 micron (optional, customizable)
Controller Universal Controller, featuring the NI™ Single-Board RIO platform
Software Invitroflow software package, with intuitive user
interface to monitor and control the CDT-20
Capacitance tank 1.6 gal
5
6
7
Configuration Dimensions Weight Power
Integrated system 38”W x 40”D x 94”H 745 lbs 120 VAC 12 A
Bench-top system 60”W X 72”D X 53”H 600 lbs 120 VAC 12 A
1
US Patent # 7,621,192 B2
2
E.g., coronary or neuro or carotid stent sizes
3
Standards require stent observation to verify pulsatile deflection
4
Customizable to your requirements up to 1,000 microns
5
Depending on sample compliance
6
With optional larger heater
7
Based on use of appropriate standards
CDT-20™ Coating Durability Tester
and Invitroflow™ are trademarks of
Dynatek Labs.
To receive a customized proposal,
contact us today at:
Dynatek Labs
105 East 4th Street
Galena, MO 65656
800.325.8252
1.417.357.6155
www.dynateklabs.com
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