FDA Approves Lutonix 035: First Drug-Coated Balloon for Blockages in Leg Arteries

The U.S. FDA has approved the first drug-coated balloon for use in opening up blockages in the peripheral arteries, specifically the superficial femoral or popliteal arteries in the leg. The Lutonix 035 was approved in Europe in 2012 but has taken an additional two years for the FDA to give it the go-ahead. An FDA panel unanimously recommended approval back in June, although there were questions regarding the results that showed no additional benefit in women above the therapy of a standard non-coated balloon.
Source: News from Angioplasty.Org - Category: Cardiology Source Type: news