The
Radial Expansion Force Gage from MSI
is designed to measure and record radial
stiffness or hoop strength during expansion
and compression of interventional devices
including: balloon expandable and self-expanding
stent and stent graft products, collagen
plugs, embolic filters, vena cava filters
and other basket type filter products.
Testing results can be useful for regulatory
submissions, pre-clinical trial testing,
competitive product testing and product
design calculations.
At
the core of the RX500 equipment is the
MSI proprietary segmental compression
mechanism which collects data from twelve
points of product contact providing a
uniform radial measurement. The RX500
equipment is activated by a precision
roller bearing system and is controlled
by a micro-stepping linear actuator and
encoder for diameter accuracy that is
specifically designed to provide a low
friction testing environment.
The
RX500 equipment was designed with international
testing recommendations in mind. These
include: the FDA guidance document titled "Non-Clinical
Tests and Recommended Labeling for Intravascular
Stents and Associated Delivery Systems",
ISO Standard 25539-1:2003(E) Titled "Cardiovascular
implants - Endovascular devices” and
in ISO/TS 15539:2000(E) Titled "Cardiovascular
implants - endovascular prostheses".
Advantages
over current expansion force measurement
techniques:
• Decreased set up time.
• Simplified data acquisition.
• Improved repeatability and reproducibility.
• Increased accuracy and resolution.
• Head can be completely encapsulated in a temperature chamber.
• Product can be deployed directly into head.
• Data strings set up for spreadsheet analysis.
• Easily calibrated.
• Low maintenance.
