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Medinol NIRflex

This article was originally published in The Gray Sheet

Executive Summary

Enrollment is now complete for an 11-center, 201-patient U.S. trial of the pre-mounted stent system, designed to maintain apposition with the vessel wall even as it changes shape, according to Medinol. Results of 30-day follow-up will be released in September, and the firm expects to submit a PMA application to FDA in the fall. The Israeli firm anticipates U.S. approval of the device in early 2003...
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