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

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.

Bard’s Lutonix Drug-Coated Balloon Shows Efficacy In Early Trial Results

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, Bard In Close Race To First FDA-Approved Drug-Eluting 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.

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