The FDA has approved the Lutonix 035 drug-eluting balloon (Bard) for percutaneous transluminal angioplasty, after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4–6mm.
The approval follows a unanimous favourable recommendation from the FDA’s Circulatory Systems Devices Advisory Panel in June 2014. The Lutonix 035 drug-eluting balloon—the first FDA-approved drug-eluting balloon in the USA—is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also utilises standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease in the femoropopliteal arteries.
FDA approval of the Lutonix 035 drug-eluting balloon was supported by results of the LEVANT 2 pivotal study, a global, prospective, single-blind, randomised, 54-site study (42 sites in the USA and 12 in Europe) that enrolled all patients under one protocol. At one year, the LEVANT 2 study demonstrated improved patency of the Lutonix 035 DCB compared to standard PTA: 73.5% vs. 56.8% (p<0.001) by Kaplan-Meier time-to-event analysis. It also demonstrated clinical benefits of sustained improvement in Rutherford Class and improved walking distance scores. The LEVANT 2 study followed a rigorous blinding protocol designed to reduce bias in the results to accurately and scientifically assess and compare the long-term performance of key clinical measures. The LEVANT clinical programme, which includes registry data, enrolled more than 1,000 patients and demonstrated robust safety of the device comparable to angioplasty, including the same low rate of distal embolic events and rate of reintervention for thrombotic events.
“The Lutonix 035 drug-eluting balloon provides physicians with an opportunity to enhance the treatment protocol for patients with occlusive disease of the femoropopliteal artery with a safe, effective method of delivering paclitaxel directly to stenosed vessels,” said Kenneth Rosenfield, section head, Vascular Medicine and Intervention chairman, Massachusetts General Hospital, professor of Medicine, Harvard University School of Medicine and LEVANT 2 principal investigator. “This DCB is a new first-line therapy for treating blockages, without closing the door to other treatment options down the road. I envision also using the Lutonix 035 DCB to complement existing therapy options.”
As part of the approval, the FDA is requiring Bard to conduct two post-approval studies. One is a five-year post-approval study of 657 patients treated with the Lutonix drug-eluting balloon to further monitor safety and effectiveness. The second is a randomized, single blind, multicentre study which will assess the safety and effectiveness of the Lutonix drug-eluting balloon in women in the United States, due to differences in observed outcomes in this group as compared to outcomes for the general study population.
The Lutonix 035 drug-eluting balloon has been available commercially in Europe since 2012.