C.R. Bard has announced the submission of the final module to support FDA approval for the Lutonix® Drug-Coated PTA Dilatation Balloon/Catheter (DCB).
Now that companies are getting into the swing of things with FDA’s new modular PMA, we expect to see more of them issuing progress reports when things are going well. And why not? After all, shareholders, physicians, competitors and industry watchers all have some interest in seeing new devices heading to market.
This time it’s the Lutonix® DCB, which is being clinically evaluated in the global, multicenter LEVANT 2 randomized investigational device exemption (IDE) trial clinical trial. This is interesting in itself because no drug-coated balloons have been granted US market access yet, although the Lutonix DCB is currently available in Europe and several other countries worldwide.
DCBs have received growing attention in recent years as physicians look for effective ways to treat diseased arteries without having to leave a permanent implant behind. The purpose of this pivotal trial is to compare the safety and efficacy of the Lutonix® DCB to standard angioplasty balloons for the treatment of peripheral arterial disease (PAD) in superficial femoral (SFA) and popliteal arteries. Data from LEVANT 2, combined with LEVANT I and the LEVANT Continued Access Safety Registry, culminated in over 1000 patients and are the foundation of the submission to the FDA.
Designed to treat atherosclerotic lesions in the SFA and popliteal arteries, the Lutonix® DCB is similar to a standard angioplasty balloon but features a proprietary coating containing a low dose of the anti-restenotic drug agent paclitaxal together with excipients sorbital and polysorbate. The combination is intended to form a highly durable coating that allows delivery and subsequent absorption of the drug to the walls of the target vessel. During the procedure, the Lutonix DCB is briefly inflated and is designed to open up the artery to restore blood flow, while at the same time delivering the drug to the artery wall to prevent restenosis.
Timothy M. Ring, chairman and chief executive officer, commented, “This submission marks a key milestone in our drug-coated balloon program, which continues to progress as expected. We look forward to interfacing with the FDA for the purpose of making this important technology available to U.S. patients.”
Source: C R Bard, Inc., Business Wire