Bard gets surprise FDA panel yes for Lutonix, but Medtronic close behind
This article was originally published in Clinica
Executive Summary
An FDA advisory panel has unexpectedly recommended approval of CR Bard’s first-of-a-kind drug-coated peripheral angioplasty balloon, Lutonix, in a unanimous vote. The decision is a turnaround after the FDA questioned the clinical benefits of Lutonix compared to that of a standard angioplasty balloon in documents released before the 12 June meeting.