C.R. Bard Enrolls Patients in U.S. Clinical Trial of Drug-Coated Balloon

C.R. Bard is enrolling patients in a new U.S. clinical trial of its drug-coated balloon. The technology could provide an alternative to traditional treatment methods for in-stent restenosis, the company said in a statement.

The multicenter, randomized study will compare C.R. Bard’s Lutonix 035 drug-coated balloon PTA catheter to a standard balloon. Lutonix is similar to a traditional balloon but is coated with a low dose of paclitaxel, an antiproliferative drug. Paclitaxel prevents scar tissue from forming around a stent or balloon and also helps keep vessels clear after surgery. The Murray Hill, N.J.-based company plans on enrolling several hundred patients at 30 test sites in the U.S., it said in a statement.

In-stent restenosis is a problem that affects many angioplasty patients, with 20 percent to 35 percent restenosis rates at 12 months. The only approved therapy in the United States for femoropopliteal artery in-stent restenosis is an angioplasty with a bare, non-drug-coated balloon. Restenosis rates with a noncoated balloon are 65 percent at 12 months.

Designed to treat atherosclerotic lesions in the SFA and popliteal arteries, the Lutonix DCB is similar to a standard angioplasty balloon, but is coated with a low dose of the anti-proliferative drug, paclitaxel, with excipients sorbitol and polysorbate. The combination forms a high-integrity coating adhesion intended to be durable enough to “stick” to the balloon during prep and transit while also allowing release of the drug to the target vessel during a 30-second balloon inflation, C.R. Bard notes. The coating is designed as adjunct therapy to standard mechanical dilatation of the vessel to restore blood flow. 

“With today’s treatment limitations, in-stent restenosis remains difficult to treat,” Carlos Mena, M.D., medical director, Vascular Medicine at Yale– New Haven Hospital and the study’s principal investigator, said in a statement. “I am excited to lead this groundbreaking study and for the potential to provide the medical community a new tool to treat patients with these complex challenges.”

The trial could also facilitate U.S. regulatory approval for the device: C.R. Bard acquired its drug-coated balloon with its $225 million purchase of Minneapolis, Minn.-based Lutonix in 2011. At the time of the companies’ merger, Lutonix was conducting a U.S. Food and Drug Administration (FDA)-approved investigational device exemption trial of its drug-coated balloons in the United States. The company submitted results from the clinical trial to the FDA but is still seeking approval for the device in America, it said in a statement. Lutonix had already secured a CE mark for the device in 2007.

With positive study results in hand, C.R. Bard hopes to grab a piece of a growing market: The global peripheral vascular market for drug-coated balloons could approach $1 billion annually over the next decade, the company said in an earlier release. Other companies also are hoping to cash in, with big names like Medtronic Inc. and Covidien plc touting positive data for their own peripheral artery devices. Germany’s Biotronik Inc. recently revealed promising results from a study of its drug-coated balloon to treat leg blood clots.