The SR1000 measures and records forces required to dislodge a balloon-expandable stent from its proper position on a balloon. The SR1000 is comprised of a multi-sectioned segmental head. One segment radially grips the balloon while the other segment captures the stent edge. Head sections separate to dislodge the stent proximally or distally from the balloon. The SR1000 utilizes stepper motor linear actuators for precise diameter control and smooth pull action. Test results can be used for regulatory submissions, competitive product testing, R&D device evaluation and inline manufacturing quality assurance.
The SR1000 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”, ASTM F2394-07 Guidance Document for Stent Securement, and ISO Standard 25539-2: 2008.
MSI designed the SR1000 to work as a stand alone unit or as an accessory to the MSI IDTE2000™ Interventional Device Testing Equipment.
SR1000 Features:
• Guide-type securement test.
• Proximal or distal displacement of stent.
• High speed data acquisition system.
• Repeatable and reproducible data.
• Quick, simple software controlled calibration.
• Real-time graphical display of force vs. displacement.
• Diameter control and force feedback on capture segments.
• Video assist with sample alignment and video capture of test.
• Data output includes: profile parameters, peak force and associated displacement.
