Drug-Eluting Balloons Inch Closer to US Approval

Shelley Wood

June 11, 2014

GAITHERSBURG, MD — A drug-eluting balloon (DEB) system, intended for the treatment of femoropopliteal artery stenosis (or restenosis), is the first to make it to an FDA Advisory Committee review and will reach that milestone this week[1]; another has shown promise in the multicenter trial needed for its own FDA premarket approval application[2].

It remains to be seen whether either of these two devices—or the many others waiting in the wings—will see their way onto the US market. A wide range of DEB systems are already in use in Europe, for both coronary and peripheral artery disease.

As previously reported by heartwire , DEBs have appeared in European Society of Cardiology guidelines since 2010, and subsequent position statements from member countries have continued to support a role for the technology. In the US, however, the ACC/AHA 2011 guidelines said only that "drug-eluting balloons were considered for formal evaluation, but there were insufficient data to formulate any formal recommendations."

Unlike drug-eluting stents, which rely on a metallic (or bioabsorbable) scaffold to elute the antiproliferative agent that inhibits restenosis, drug-eluting balloons leave no stent behind, relying instead on the lipophilic properties of drugs like paclitaxel, eluted from the balloon itself. The idea of delivering an antiproliferative agent without needing a stent is particularly attractive in the periphery, where high mobility in these vessels increases the risk of stent fracture. Drug-eluting balloons are also being studied in de novo coronary artery disease, particularly in bifurcations and small vessels, and in in-stent restenosis, the aim being to avoid a metal-on-metal scenario.

The device under review Thursday is the Lutonix 035 (Bard) drug-coated balloon PTA catheter. According to FDA briefing documents, Bard's application rests primarily on clinical data from the pivotal LEVANT 2 trial (conducted partly in the US), plus the earlier LEVANT 1 trial.

In briefing documents published online, FDA reviewers say LEVANT 2 overall supports the safety and efficacy of the Lutonix device but point out a range of study flaws, including the fact that the primary end point was met in the intention-to-treat analysis, but not in the per-protocol (PP) analysis. There was also no difference in the primary patency rate at one year in the PP group compared with the non-DEB controls.

Next Up

The second device approaching an FDA review is Medtronic's IN.PACT Admiral drug-coated balloon studied in 331 patients at 57 sites across the US and Europe. Presented at the Charing Cross Interventional Symposium earlier this spring, the IN.PACT SFA trial showed significant reductions in the rate of clinically driven revascularization and improved patency with the DEB system, as compared with plain-old balloon angioplasty.

No date has been announced for an FDA review of the IN.PACT Admiral system. The agency's Circulatory System Devices Panel will vote on the approvability of the Lutonix device Thursday.

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