Product News


Published: January 19, 2012
Find more content on: Testing and Inspection, Regulatory and Compliance

Stent Securement Testing Equipment Can Be Used for Quality Assurance and Regulatory Submissions


The SR1000 stent securement testing equipment from Machine Solutions Inc. is designed to measure and record the force required to dislodge a balloon-expandable stent from its proper position on a balloon. The SR1000 has a multisectioned segmental head, one segment of which radially grips the balloon while another captures the stent edge. These head sections separate to dislodge the stent proximally or distally from the balloon. The SR1000 uses 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 evaluations and inline manufacturing quality assurance.

MSI designed the stent securement tester to work as a standalone unit with an optional submersible configuration for testing in aqueous, temperature-controlled environments. The system also can be purchased as an add-on to the company’s interventional device testing equipment. The SR equipment has been designed with international testing recommendations in mind. These include US FDA guidance document 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.
Machine Solutions GmbH
Munich, Germany  +49 1737 773 317

 

Yvonne Klöpping


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