The FDA approved Medtronic’s drug-coated balloon as a treatment for peripheral artery disease (PAD), giving physicians more options for treating patients with disease in the superficial femoral artery and the popliteal artery.
The approval is based on data from the IN.PACT SFA randomized clinical trial, in which the IN.PACT Admiral drug-coated balloon was shown to outperform percutaneous transluminal angioplasty (PTA) at 12 months. The clinically driven target lesion revascularization rate for patients in the drug-coated balloon group was 2.4 percent compared with 20.6 percent for patients on the control group.
The primary patency rate was 82.2 percent in the drug-coated balloon group vs. 52.4 percent for the PTA group at one year. They defined primary patency as freedom from restenosis and clinically driven target lesion revascularization.
The study enrolled 331 patients at 57 sites across Europe and the United States; 95 percent of the patients had severe or moderate claudication at the time of enrollment.
A substudy on patients with diabetes, presented at the 2014 Vascular Interventional Advances meeting in Las Vegas, also showed positive results. At one year, the target lesion revascularization rate was 3.7 percent for the drug-coated balloon group vs. 23.1 percent for control group and the primary patency rate was 82.7 percent vs. 62.3 percent.
The IN.PACT Admiral drug-coated balloon, which received CE mark in Europe in 2009, adds to the growing number of treatments for patients with PAD. Those include Bard’s Lutonix paclitaxel-coated balloon, which was approved by the FDA in October, 2014; and Cook’s Zilver PTX drug-eluting peripheral stent, which was approved in 2012.