C.R. Bard ($BCR) enrolled its first patient 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, NJ-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% to 35% restenosis rates at 12 months. The only approved therapy in the U.S. for SFA-ISR is an angioplasty with a bare, non-drug-coated balloon. Restenosis rates with a noncoated balloon are 65% at 12 months.
"With today's treatment limitations, in-stent restenosis remains difficult to treat," Dr. Carlos Mena, 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-based Lutonix in 2011. At the time of the companies' merger, Lutonix was conducting an FDA-approved IDE trial of its drug-coated balloons in the U.S. The company submitted results from the clinical trial to the FDA but is still seeking approval for the device in the U.S., it said in a statement. Lutonix had already secured a CE mark for the device in 2007.
While the company did not disclose a specific timeline for FDA approval of its device, the current trial's primary endpoint is a 12-month period, Lutonix President Abithal Raji-Kubba told FierceMedicalDevices.
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 $1 billion annually over the next decade, the company said in an earlier release. Other companies are also hoping to cash in, with big names like Medtronic ($MDT) and Covidien ($COV) touting positive data for their own peripheral artery devices. Germany's Biotronik recently revealed promising results from a study of its drug-coated balloon to treat leg blood clots.
Editor's Note: This article was updated to reflect new information from Lutonix President Abithal Raji-Kubba regarding the company's plans for FDA approval and study goals.
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