FDA Approves First Drug-Coated Balloon, Lutonix 035, for Vascular Disease

Shelley Wood


October 10, 2014

SILVER SPRING, MD — The US FDA has approved the first drug-coated balloon (DCB) for the treatment of vascular disease, meaning US patients will at last have access to a therapy available in Europe for several years[1].

The FDA approval of the Lutonix 035 paclitaxel-coated balloon (Bard) follows a unanimous vote by the agency's Circulatory System Devices panel members in June, all of whom voted yes to questions of safety, efficacy, and risk vs benefit.

The Lutonix device is intended to be used to treat stenotic or obstructive lesions in the femoropopliteal arteries to improve limb perfusion.

Evidence supporting the safety and effectiveness of the Lutonix DCB came from preclinical testing, as well as three clinical studies, one in Europe, one in both Europe and the US, and a third, still ongoing, in Europe and the US. The FDA has also mandated two postapproval studies, one a registry looking at ongoing safety and efficacy with the device, the other a randomized, single-blind, multicenter trial in women in the US, since this group was identified in earlier studies as experiencing less benefit in the preapproval studies and was a key concern of panel members during the June advisory committee meeting.


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