The U.S. FDA’s Circulatory System Devices Advisory Panel provided a unanimous favorable recommendation to FDA for use of C. R Bard’s Lutonix® Drug Coated Balloon PTA Catheter (DCB) in the U.S.
Yesterday we wrote about Medtronic’s drug coated balloon and the company’s quest for that elusive first-of-its-kind approval. C.R.Bard is sounding equally punchy and is arguably further down the tracks, having gained the panel’s unanimous vote.
PTA balloons are a well-established and accepted treatment for peripheral arterial disease (PAD) according to the American College of Cardiology and American Heart Association guidelines. The Lutonix® DCB is a standard angioplasty balloon that is coated with a low dose of the anti-restenotic agent, paclitaxel, and is designed as adjunct therapy to standard mechanical dilatation of the vessel to restore blood flow. Successful treatment of PAD in the femoropopliteal arteries requires improved blood flow (patency) for longer periods of time. PTA is typically the first and preferred method to treat patients with PAD.
The Lutonix® DCB is currently under review by FDA for improving luminal diameter and reducing the incidence of restenosis for the treatment of obstructive de novo or non-stented restenotic lesions (≤ 15 cm in length) in native femoropopliteal arteries with reference vessel diameters of 4 mm to 6 mm.
Data presented at the advisory committee meeting included one-year primary endpoint data from the LEVANT 2 pivotal study, which is a global, prospective, single-blind, randomized, 54-site study (42 sites in the U.S. and 12 in Europe) that enrolled all patients under one protocol. C.R.Bard tells us that LEVANT 2 investigators have submitted a manuscript for publication with a top-tier medical journal.
C.R.Bard is pointing to what it calls a raised bar for scientific rigor in its LEVANT 2 study, claiming reduced bias by blinding the physician performing the assessment, which it argues speaks to published data that suggest trials with less rigorous blinding methodologies have shown physicians to intervene more often in the control arm than in the treatment arm, even when presented with similar objective results such as binary restenosis. In spite of this vigorous exclusion of bias, the results are impressive with significantly better primary endpoint of primary patency at one year than standard PTA.
The FDA will now consider the positive recommendation of the advisory panel in its review of the PreMarket Approval (PMA) Application that was submitted by C. R. Bard in November 2013. Currently, the Lutonix® DCB is available commercially in Europe.
“The PAD patient population is growing and the variety of treatment needs for these challenging patients is increasing,” said Kenneth Rosenfield, M.D., Section Head for Vascular Medicine and Intervention, Massachusetts General Hospital and LEVANT 2 Co-Primary Investigator. “There is a need to improve upon the current well-established treatment modality and the Lutonix® DCB can be another tool to treat PAD in the difficult anatomy of the femoropopliteal artery without leaving an implant behind.”
Timothy M. Ring, chairman and chief executive officer of C. R. Bard, commented, “We are hopeful that the unanimous positive recommendation for Lutonix® DCB is the next step in establishing a new standard of care for those patients in the U.S. confronted with femoropopliteal occlusive disease. Clinicians have been calling for a first-line alternative treatment to expand the therapy options for this painful, progressive and debilitating disease and we look forward to working closely with the FDA as it completes its review.”
Source: C.R.Bard, Inc., Business Wire