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STENT SECURITY VALIDATION
DISA Med Tech has for the past seven years undertaken numerous stent
retention validations according to FDA and EEC requirements. The company
has purpose built equipment for these tests. |
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DEPLOYMENT AND BALLOON FATIGUE
VALIDATION
DISA Med Tech has experience in undertaking stent system deployment
analysis (compliance, rated burst, etc) and balloon fatigue using
a Crescent machine in accordance with the American and European standards. |
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STENT FATIGUE ANALYSIS
Both the FDA and the EEC standards for coronary stents require the
implant to pass a ten-year fatigue cycle test. The standards require
simulation of the physiological conditions imposed on the implant
in the coronary vessels. The DISA Med Tech stent fatigue machine simulates
the in vivo loads at up to 60 times the cycle rate to complete
the test in three months. DISA Med Tech provides full metallurgical
and SEM analysis to the requirements of the European standards.
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