An FDA advisory panel voted unanimously in favor of approval for a drug-coated balloon to treat patients with peripheral artery disease (PAD). The first-of-its-kind device is indicated for use in the femoropopliteal arteries.
The Circulatory Systems Device Advisory panel reviewed clinical trial results on C.R. Bard’s LUTONIX 035 Drug Coated PTA Balloon, a drug-coated peripheral percutaneous transluminal angioplasty balloon. The balloon is designed as treatment for obstructive de novo or nonstented restenotic lesions that are 15 cm or less in length. The design includes an over-the-wire catheter with paclitaxel drug coating on the surface of the balloon.
Reviewers evaluated results from the pivotal LEVANT 2 trial, which randomized 476 patients from the U.S. and Europe who received either drug-coated balloon therapy or standard treatment (“plain old” balloon therapy). The safety endpoint was a composite of freedom from all-cause perioperative death and freedom at one year from index limb amputation, re-intervention and death at one year.
The efficacy endpoint was 12-month primary patency, defined as the absence of target lesion restenosis and freedom from target lesion revascularization.
At one year, the drug-coated group showed a higher patency rate, at 73.5 percent vs. 56.8 percent and a higher 12-month freedom from safety events rate, at 83.9 percent vs. 79 percent. The rate of target limb revascularization at 12 months was 15.4 percent in the drug-coated balloon group and 21 percent in the control group. The trial met its superiority patency endpoint and its noninferiority safety endpoint.
The FDA also pointed out some differences in results between female and male patients in the U.S. Women in the U.S. in the control group vs. the drug-coated balloon group had a higher freedom from primary safety events (80 percent vs. 74 percent) and higher patency rates (86.3 percent vs. 85 percent). This created a difference between results for patients inside and outside the U.S.
The FDA often but not always follows the advice of its advisory panels.