The RX750 is designed to measure and record radial stiffness and strength of self expanding and balloon expandable devices within a temperature controlled water bath. Many new devices are comprised of materials with mechanical properties that are fluid and temperature dependent. This off-the-shelf solution measures force decay over time and radial strength and stiffness in an aqueous environment. The RX750 utilizes the same integrated high speed data acquisition system and proprietary software as the RX550/650, generating repeatable and reproducible data to facilitate knowledgeable and rapid device design changes.
At the core of the RX equipment is the MSI proprietary segmental compression mechanism which collects data from twelve product contact points providing uniform radial measurement. The RX750 system has an optional dual tank base for testing consecutively in cold and then warm water to simulate loading and body temperature deployment. 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. Test results can be used for regulatory submissions, competitive product testing, R&D device evaluation and inline manufacturing quality assurance.
The RX equipment is designed with international testing recommendations in mind. These include: FDA guidance document titled “Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems”, ISO Standards 25539-1:2003(e), 25539-2: 2008 and 15539:2000(E).
Radial
Expansion Features:
• High speed data acquisition system.
• Quick set-up.
• Repeatable and reproducible data.
• 40mm segment length is fully submersible in temperature controlled water bath.
• Software capable of replaying multiple data sets for fast and easy comparisons.
• Software has force control capability for measuring diameter creep over time.
• Data output setup for spreadsheet analysis.
• Interchangeable load cells for optimal force resolution.
• Data output includes: lab notes, maximum, minimum and average force.
• Quick and easy software controlled calibration.
