FDA Advisory Panel Set to Review Bard's Lutonix DCB

May 14, 2014—A Circulatory System Devices Panel of the Medical Devices Advisory Committee of the US Food and Drug Administration (FDA) will hold a public meeting to discuss, make recommendations on, and vote on information related to the premarket approval application for Bard Peripheral Vascular’s Lutonix 035 drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter. The meeting will be held on June 12, 2014, from 8 am to 6 pm at Holiday Inn Express/Highlands in Germantown, Maryland.

The Lutonix DCB is an over-the-wire PTA catheter with a paclitaxel-based drug coating on the surface of the balloon. The device is compatible with an 0.035-inch guidewire and has balloon sizes ranging from 4 to 6 mm in diameter and 40 to 100 mm in length. The Lutonix DCB catheter has working lengths of 75, 100, and 130 cm.

The proposed indications for use are for improving luminal diameter for the treatment of obstructive de novo or nonstented restenotic lesions (≤ 15 cm in length) in native femoropopliteal arteries having reference vessel diameters of 4 to 6 mm.

The FDA intends to make background material available to the public no later than 2 business days before the meeting. If the FDA is unable to post the background material on its website before the meeting, the background material will be made publicly available at the location of the advisory committee meeting and the background material will be posted on the FDA’s website after the meeting. The website for background material is http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm.

Interested persons may present data, information, or views on issues pending before the committee orally or in writing. Further information and instructions for presenters and attendees is available online in the FDA notice at http://www.fda.gov/advisorycommittees/calendar/ucm398000.htm. The FDA contact person is Jamie Waterhouse at the FDA Center for Devices and Radiological Health, who may be reached at Jamie.Waterhouse@fda.hhs.gov; (301) 796-3063.