Originally Published MPMN
Originally Published MPMN July 2003
INDUSTRY NEWSMSI Puts Catheter and Stent-Delivery Products to the Test
|A view of the IDTE showing the tortuous path submerged in water.|
Data gathered during testing of catheters and stent-delivery products can have a direct impact on a manufacturer's product design. Also, end-users such as interventional cardiologists or radiologists will use this information in employing the devices. Realizing the value of accurately measuring performance criteria, Machine Solutions Inc. (MSI; Flagstaff, AZ; www.machinesolutions.org) recently introduced its Interventional Device Tracking Equipment (IDTE) at the MD&M East 2003 trade show in New York City.
|The IDTE from Machine Solutions Inc. measures performance characteristics of catheters and stent-delivery products.|
A PC controls the IDTE, which has an adjustable PFA track that enables both 2- and 3-D testing. "The track can be configured to simulate the different parts of a patient's anatomy," says James P. Kasprzyk, the company's director of global marketing. Typical configurations mimic the aortic arch for coronary procedures, or the superficial femoral artery or iliac branches for peripheral applications. Stepper motors push catheters through the tortuous path. The path is submersed in water maintained at body temperature.
A data-collection feature samples up to 100 data points per centimeter of the product being tested. The information is saved in a spreadsheet format for further analysis. It can be used in FDA submissions, pre-clinical-trial testing, marketing literature, competitive product testing, or product-design calculations.
The IDTE measures catheter characteristics including push efficiency, guidewire movement, device crossability, trackability force, catheter flexibility, and device lubricity. Stents will be tested for device lubricity, expansion force, and retention force.
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