Drug-Eluting Balloon Gets Unanimous Yes from FDA Advisors

Shelley Wood

June 13, 2014

GAITHERSBURG, MD — The first drug-eluting balloon (DEB) to go before a panel of advisors to the US Food and Drug Administration has been given a unanimous vote of support[1].

On Thursday, the FDA's Circulatory System Devices panel members all voted in favor of recommending approval of the Lutonix drug-coated balloon PTA catheter (CR Bard), and all voted yes to questions of safety, efficacy, and risk vs benefit.

The system, which elutes paclitaxel during balloon inflation, is intended for use in the femoropopliteal arteries, where risk of stent fracture typically precludes the use of drug-eluting stents to prevent restenosis.

Over the course of the day's deliberations, several panel members pointed to deficiencies in the LEVANT 2 study program, which missed both its primary safety and efficacy end points in the per-protocol analysis, although it met them according to an intention-to-treat analysis, a discrepancy that panel members credited to an underpowered trial. Panel experts also expressed concern over the blunted efficacy in female patients, a finding that will require further study. Several analyst reports in advance of the Thursday meeting had predicted a no vote from the FDA, given the problems with the study—predictions that did not pan out yesterday.

If the FDA follows its panel's advice—which it typically does—the Lutonix will be the first drug-eluting balloon on the US market.

The indication being sought by the manufacturer is "improving luminal diameter and reducing the incidence of restenosis for the treatment of obstructive de novo or nonstented restenotic lesions (<15 cm in length) in native femoropopliteal arteries with reference vessel diameters of 4 mm to 6 mm," a CR Bard press release notes.

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

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