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Novoste Beta-Cath

This article was originally published in The Gray Sheet

Executive Summary

Intravascular beta radiation device premarket approval application is submitted to FDA to treat in-stent restenosis and will receive expedited review by the agency, the firm announces April 17. The PMA is largely based on results of the START (Stents and Radiation Therapy) trial (1"The Gray Sheet" March 20, p. 12)

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