FDA Panel Date Set For Bard’s Lutonix Drug-Coated Balloon
This article was originally published in The Gray Sheet
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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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.
Six-month data from the rigorous Levant 2 trial, presented at the TCT conference in San Francisco, show peripheral angioplasty with Bard’s Lutonix paclitaxel-coated balloon reduces restenosis compared with regular balloon angioplasty. The findings give the company an edge in the race to be the first on the U.S. market with a drug-coated peripheral angioplasty balloon.
Medtronic says it reached the necessary trial enrollment to support PMA approval for its IN.PACT Admiral drug-eluting balloon catheter to treat atherosclerosis in the superficial femoral artery. On the same day, CR Bard said it was prepared to submit its final PMA module for its Lutonix drug-eluting balloon by year’s end.