October 13th, 2014

First Drug-Coated Balloon Approved by FDA for Leg Blockages

The FDA today announced that it had approved for use in the U.S. the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the superficial femoral and popliteal arteries. The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by CR Bard and has been available in Europe since 2012.

“Peripheral artery disease can be quite serious. Preventing further blockage of arteries is just as important as removing the initial blockage” said William Maisel, the deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, in an FDA press release. “The clinical data show that Lutonix DCB may be more effective than traditional balloon angioplasty at helping to prevent further blockage in the artery.”

The Lutonix DCB “is a new first-line therapy for treating blockages, without closing the door to other treatment options down the road,” said Harvard University’s Kenneth Rosenfield, in a CR Bard press release. Rosenfield said the new device can also be used “to complement existing therapy options.”

Rosenfield was the principal investigator of the LEVANT 2 pivotal study which randomized 101 patients to the Lutonix DCB or conventional balloon angioplasty. At six months, fewer than half the patients treated with conventional therapy did not require additional treatment for their peripheral disease. By contrast, 71.8% of patients in the Lutonix DCB did not need additional treatment.

The FDA is requiring the manufacturer to perform two post-approval studies. The first will monitor the long-term safety and effectiveness of the device in 657 patients. The second is a randomized trial designed to assess the safety and efficacy of the device in women.

Rick Lange was a member of the FDA advisory panel that recommended approval of the Lutonix DCB earlier this year. He noted that the panel wrestled with some difficult issues, including the apparent lack of benefit for women in the trial.  But the panel voted unanimously to recommend approval, said Lange, in the belief that the device was both safe and at least as effective as conventional therapy. “It’s a little easier than a stent since you’re not leaving anything inside,” he said.



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