Radial Force Testing (Dry)
The RX550/650 is designed to measure and record radial stiffness and strength, chronic outward force during expansion, and radial reactive force during compression of interventional devices. The RX550/650 is ideal for testing balloon expandable stents, self-expanding stents, stent grafts, collagen plugs, embolic filters, vena cava filters, and other radially expanding devices. The MSI RX550/650 radial expansion force gage facilitates knowledgeable and rapid device design changes by using an integrated high speed data acquisition system and proprietary software to generate repeatable and reproducible data.
MSI’s proprietary segmental compression mechanism is the core technology in the RX equipment, which collects data from 12 product contact points and provides uniform radial measurement. The RX equipment uses an encoder for diameter accuracy, a linear actuator for activation, and a precision roller bearing system 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.
MSI’s RX equipment supports conformity with the following international recommendations:
- S. Food and Drug Administration. (2010.) Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems. Center for Devices and Radiological Health, Silver Spring, MD, USA.
- ISO (2003). ISO 25539-1 Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses. International Organization for Standardization, Geneva, Switzerland.
- ISO (2000). ISO/TS 15539Cardiovascular implants – Endovascular prostheses. International Organization for Standardization, Geneva, Switzerland.