C.R. Bard ($BCR) won a unanimous vote from an FDA advisory panel for its drug-eluting balloon catheter, setting the stage for the device’s full regulatory approval.
The FDA’s Circulatory System Devices Advisory Panel recommended that the company’s Lutonix drug-coated balloon PTA catheter (DCB) be approved in the U.S. to treat peripheral artery disease (PAD) by dilating stenotic or obstructive lesions in the femoropopliteal artery. C.R. Bard’s balloon catheter is coated with paclitaxel, which inhibits restenosis and improves blood flow to the arteries for longer periods of time. If Lutonix clears its last regulatory hurdle, it would be the first FDA-approved DCB product available in the U.S., the company said in a statement. The device scored a CE mark in 2010 and is sold commercially in Europe.
“We are hopeful that the unanimous positive recommendation for Lutonix DCB is the next step in establishing a new standard of care for those patients in the U.S. confronted with femoropopliteal occlusive disease,” CEO Timothy M. Ring said in a statement. “Clinicians have been calling for a first-line alternative treatment to expand the therapy options for this painful, progressive and debilitating disease and we look forward to working closely with the FDA as it completes its review.”
The agency based its decision in part on a randomized, 54-site study that compared Lutonix to traditional balloon angioplasty. At the primary efficacy endpoint, C.R. Bard’s drug-eluting device demonstrated reduced binary restenosis–26.5% compared with 43.2% for uncoated balloons. Lutonix also significantly reduced lesion restenosis and cut down on lesion revascularization. In March, the company enrolled its first patient in a new U.S. trial of its drug-eluting balloon catheter and plans on testing the device for several coronary and peripheral indications.
C.R. Bard is not the only company hoping to expand into the drug-coated balloon market. Last year, Covidien ($COV) laid down an undisclosed sum on California’s CV Ingenuity to pick up a PAD balloon, and Medtronic ($MDT) submitted the first portion of its FDA application for its own drug-coated balloon catheter. In March, Germany’s Biotronik touted positive 6-month study results that showed its drug-eluting device produced fewer adverse events than a standard balloon angioplasty.
Smaller operations are also looking for their piece of the pie. Last month, Spectranetics ($SPNC) acquired cardiovascular balloon maker AngioScore for $230 million to get its hands on the company’s drug-coated balloon platform. The Colorado-based company expects to close the deal by the end of this month, it said in an earlier statement.
Source: www.fiercemedicaldevices.com; Emily Wasserman; June 13, 2014.