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FDA Questions Bard’s Data In Advance Of Panel For Lutonix Drug-Coated Balloon

This article was originally published in The Gray Sheet

Executive Summary

FDA’s Circulatory System Devices Panel will review Bard’s PMA for Lutonix, the first-of-its-kind drug-coated peripheral angioplasty balloon. The submission relies mainly on the one-year results of the LEVANT 2 trial, a 476-patient randomized non-inferiority trial comparing Lutonix to a standard peripheral balloon catheters.

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