FDA
13th June 2014

Lutonix Drug-Eluting Balloon Gets Unanimous Yes from FDA Panel

During this meeting, the Circulatory System Device Panel discussed and voted on information related to the premarket approval application for the LUTONIX 035 Drug Coated Balloon PTA Catheter sponsored by Lutonix, Inc. 

Lutonix Drug-Eluting Balloon Gets Unanimous Yes from FDA Panel

During this meeting, the Circulatory System Device Panel discussed and voted on information related to the premarket approval application for the LUTONIX 035 Drug Coated Balloon PTA Catheter sponsored by Lutonix, Inc.  The LUTONIX 035 Drug Coated Balloon PTA Catheter (LUTONIX DCB) is an over-the-wire percutaneous transluminal

The proposed indications for use are for improving luminal diameter for the treatment of obstructive de novo or non-stented restenotic lesions (≤15cm in length) in native femoropopliteal arteries having reference vessel diameters of 4 mm to 6 mm. angioplasty (PTA) catheter with a paclitaxel-based drug coating on the surface of the balloon.  The LUTONIX DCB is compatible with a 0.035” guidewire and has balloon sizes ranging from 4 millimeters (mm) to 6 mm in diameter and 40 mm to 100 mm in length. The LUTONIX DCB catheter is available in 75 centimeters (cm), 100 cm and 130 cm working lengths.

There were three voting questions during this meeting. The first question asked the panelists to provide their vote regarding whether there is reasonable assurance that LUTONIX 035 Drug Coated Balloon PTA Catheter is safe for use in patients who meet the criteria specified in the proposed indication. The second question asked panelists if they felt LUTONIX 035 Drug Coated Balloon PTA Catheter was effective for use in patients meeting the criteria specified in the proposed indication. Lastly, the panelists were asked if the benefits of using LUTONIX 035 Drug Coated Balloon PTA Catheter outweighed the risks in patients who meet the criteria specified in the proposed indication. 

Although the results of this meeting were positive overall, several panel members pointed out limitations in the LEVANT 2 study program which missed both its primary safety and efficacy endpoints in the per-protocol analysis. However, the study met these endpoints according to an intention-to-treat analysis which panelists attributed to the trial being underpowered. Panelists also noted that further study is required regarding the blunted efficacy in female patients.

In Europe, several drug-eluting balloons already hold CE Mark approval. They are used in peripheral artery disease, coronary artery in-stent restenosis and in specific de novo disease where operators believe a metal stent is unsuitable.

If the FDA follows the advice of its panel, as it typically does, the Lutonix will be the first drug-eluting balloon on the US.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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