An FDA advisory panel voted against a favorable recommendation for BD‘s Lutonix catheter-based, drug-coated balloon for use below the knee.
The FDA’s Circulatory System Devices Advisory Panel yesterday voted 15-to-2 in favor of the issue of safety when Lutonix is used as intended and voted 15-to-2 against the issue of a reasonable assurance of effectiveness. The panel also voted 14-to-3 against whether the benefits outweigh the risks. There was one abstained vote for each measure.
The Lutonix 014 Drug-Coated Balloon PTA catheter had a proposed indication for use for percutaneous transluminal angioplasties of obstructive de novo or non-stented restenotic lesions in popliteal, tibial and perineal arteries up to 320 mm in length. The advisory panel convened to provide input and recommendations to the FDA to support the agency’s review of Lutonix in the treatment of below-the-knee arteries in patients with critical limb ischemia.
Information presented during the panel meeting included six-month primary endpoint data and safety data out to 36 months from the Lutonix BTK IDE pivotal trial that enrolled 462 patients from the U.S., Europe, Canada and Japan in a multicenter, prospective, single-blind, randomized trial.
“While the panel’s vote on the question of safety was favorable, their votes on effectiveness and risk-benefit focused on study design and the challenges of executing a trial over eight years in this complex patient population,” said J.D. Meler, VP of medical affairs for BD’s peripheral intervention business.
“We thank FDA and the panel for the opportunity to bring these important data to light in this area of unmet need, and thank the clinicians, patients and advocates who shared their personal thoughts and experiences with the panel,” Meler said in a news release.
The FDA denied the Lutonix drug-coated balloon catheter’s approval for use below the knee in early 2019. At the time, the agency said that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices.
