The MSI RX55 radial expansion force gage integrates a high speed data acquisition system to increase the repeatability and reproducibility of testing data. The RX550/650 is designed to measure and record radial stiffness, radial reactive force during compression and chronic outward force during expansion and compression of interventional devices and is compatible with balloon expandable stents, self-expanding stents, stent graft products, collagen plugs, embolic filters, vena cava filters and other radial expanding intravascular devices. Testing results data can be useful for regulatory submissions, pre-clinical trial testing, competitive product testing and product design.
At
the core of the RX equipment is the MSI
proprietary segmental compression mechanism
which collects data from twelve product
contact points providing a uniform radial
measurement. The RX equipment utilizes
an encoder for diameter accuracy a linear
actuator for activation and a precision
roller bearing system that is specifically
designed to provide a low friction testing
environment.
The
RX 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”.
Radial
Expansion Features:
• High speed data acquisition system.
• Improved motion control.
• Minimal set up time.
• Repeatable and Reproducible Date.
• 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 spread sheet analysis.
• Data output includes lab notes and max, min and average force.
• Easily calibrated.
• Low maintenance.
