FDA Panel Date Set For Bard’s Lutonix Drug-Coated Balloon
This article was originally published in The Gray Sheet
Executive Summary
The agency’s Circulatory System Devices Panel will meet June 12 to consider Bard’s PMA, supported by data from Levant 2, a 476-patient randomized non-inferiority trial comparing Lutonix to a standard peripheral balloon catheter for the treatment of stenosis of the femoropopliteal arteries.
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