FDA Approves Bard’s Lutonix 035 Drug-Coated Balloon Catheter
October 10, 2014—Bard Peripheral Vascular, Inc. announced the US Food and Drug Administration (FDA) approval of the Lutonix 035 drug-coated balloon (DCB) catheter for percutaneous transluminal angioplasty (PTA), after predilatation, for the treatment of de novo or restenotic lesions up to 150 mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4 to 6 mm. The Lutonix DCB will be the first FDA-approved DCB available in the United States. In Europe, the Lutonix DCB has been commercially available since 2012.
In June 2014, the company announced that the device received a unanimous favorable recommendation from the FDA’s Circulatory Systems Devices Advisory Panel.
Bard describes the Lutonix 035 DCB as an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel that also utilizes standard mechanical dilatation of the vessel to restore bloodflow for patients with peripheral arterial disease in the femoropopliteal arteries.
FDA approval of the Lutonix 035 DCB is supported by results of the LEVANT 2 clinical pivotal study. LEVANT 2 is a global, prospective, single-blind, randomized, 54-site study (42 sites in the United States and 12 in Europe) that enrolled all patients under one protocol.
At 1 year, the LEVANT 2 study demonstrated improved patency of the Lutonix 035 DCB compared to standard PTA (73.5% vs 56.8%; P < .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 company noted that 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 program, which includes registry data, enrolled more than 1,000 patients and demonstrated robust safety of the device comparable to PTA, including the same low rates of distal embolic events and of reintervention for thrombotic events.
LEVANT 2 Principal Investigator Kenneth Rosenfield, MD, commented in Bard’s press release, “The Lutonix 035 DCB 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. 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.” Dr. Rosenfield is Section Head of Vascular Medicine and Intervention Chairman at Massachusetts General Hospital and Professor of Medicine at Harvard University School of Medicine in Boston, Massachusetts.
In a separate announcement, the FDA advised that as part of the approval the agency is requiring Bard to conduct two postapproval studies. One is a 5-year postapproval study of 657 patients treated with the Lutonix DCB to further monitor safety and effectiveness. The second is a randomized, single-blind, multicenter study that will assess the safety and effectiveness of the Lutonix DCB in women in the United States, due to differences in observed outcomes in this group as compared to outcomes for the general study population.