SVP-24 Stent Tester

SVP-24 Stent Tester

Dynatek’s Stent and Vascular Prosthesis Tester utilizes a Hyper Drive linear motor to produce an adjustable bellows compression which allows for physiologically relevant stent loading conditions for up to 24 test samples from physiological to accelerated testing rates of up to 150Hz.

Dynatek’s SVP-24 features a highly accurate and easy to use laser micrometer system that provides real-time mock vessel distention feedback that can either be used to monitor the test or to control the test in closed-loop operation.

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

SVP-24 Stent Tester
  • Compact design allows for smaller footprint than previous systems.
  • Ability to test up to 24 samples simultaneously under precisely controlled test parameters.
  • Advanced Universal Controller with unmatched data collection capability.
  • FDA accepted with appropriate documentation.
  • Data logging to TDMS file which can be accessed by Excel or other software such as DIAdem1 and Matlab1, for managing, analyzing, and reporting the test data collected.
  • Advanced frequency, temperature, and pressure control gives 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 tube OD.
  • Long life electromagnetic Hyper Drive linear motor.
  • Design allows for easy access to test samples.
  • Universal Controller allows for expansion of the SVP-24 system to accommodate future host computer technology.
  • Future upgrades with advanced SCADA technology allow complete lab monitoring of all machines from a single computer.
  • Real-time sample pressure and stent deflection adjustments without affecting data collection.
    1
    Not included

Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
ISO Link

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

Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
ISO Link

Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
ISO Link

Standard Guide for Testing Absorbable Stents
ASTM Link

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

Dynatek’s SVP-24 Stent Tester Specifications

Description
Specifications
Additional Information
Number of test samples:
24 test samples
24 test samples standard
Mock vessel configuration:
Straight, curved, or bifurcated
Additional special configurations upon request
Mock vessel length (straight) :
Adjustable to ≤ 140 mm
End effects should be considered
Mock vessel diameter range:
≈2 mm to 12 mm
Typical distention:
0.3% to 18% of stent or mock vessel OD
 Full physiological range possible
Maximum distention:
Limited by mock vessel properties
  57 mL max volume per stroke
Testing fluid:
PBS or distilled water
Not limited to distilled water
Fluid temperature:
Ambient to ≤ 45⁰C
Temperature control accurate to +/- 0.3°C of set temperature
Test monitoring: Stent deflection, mock vessel distension, pressure Stent deflection requires high speed camera (best method)
Automatic test control method: mock vessel distention
optional laser micrometer

Module
Dimensions
Power Requirement
Weight
SVP-24
70”W x 25”D x 44”H
120 VAC 12 A
221 lbs (complete system)

Manifold options:

SVP-24
2-12 mm
up to 24 samples

Available Add-ons

• Various diameters of graft tube adapters and quick disconnects for different test sample sizes.
• Mounting fixture to assist sample preparation.
• Option to allow individual samples to be removed or replaced without interrupting the test.
• UPS (Uninterruptable Power Supply) system.
• Adapters for catheter deployment of stents on the tester.
• Other custom modifications at customer request.

Specifications subject to change.

 

 

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