MONDAY, Oct. 13, 2014 (HealthDay News) -- The first drug-coated balloon catheter designed to clear narrowed or blocked arteries in the thigh and knee has been approved by the U.S. Food and Drug Administration.
The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter has a balloon coated with the drug paclitaxel, which may help prevent re-narrowing of the affected artery after the clearing procedure. The device was evaluated in clinical studies involving more than 500 people. In one study, after six months, about 72 percent of those treated with the Lutonix device did not require additional treatment for peripheral artery disease, compared to nearly half of those who had a conventional artery-clearing procedure, the FDA said.
Reported adverse reactions to the device included leg and chest pain, abnormal tissue growth, and patients who required additional treatment. The device should not be used among people with bleeding disorders, allergy to the drug paclitaxel, breastfeeding or pregnant women, or men intending to father children.
"Peripheral artery disease can be quite serious. Preventing further blockage of arteries is just as important as removing the initial blockage," said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health. "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 FDA said that it has ordered the manufacturer, Lutonix Inc. of New Hope, Minn., to conduct two post-marketing studies of the device.
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