Government and Regulations

First drug-coated angioplasty balloon approved for PAD



A drug-coated angioplasty balloon catheter has been approved for treating peripheral artery disease, the first such device approved for this use, the Food and Drug Administration announced on October 10.

The device is the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB), manufactured by Lutonix; its outer surface is coated with paclitaxel, “which may help to prevent” restenosis after the angioplasty procedure, according to the FDA statement announcing the approval. “The clinical data show that Lutonix DCB may be more effective than traditional balloon angioplasty at helping to prevent further blockage in the artery,” Dr. William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the statement.

Approval was based on the results of three clinical trials and nonclinical testing:

• A randomized, multicenter study of 101 people in Europe, which found that after 6 months, no further treatment for PAD was needed in almost 72% of the patients treated with Lutonix DCB, compared with almost 50% of those treated with conventional balloon angioplasty.

• A single-blind, multicenter, randomized study of 476 people in the United States and Europe, which found that 65% of those randomized to treatment with Lutonix DCB had no restenosis at 12 months, compared with roughly 53% of those randomized to treatment with conventional balloon angioplasty.

• A single-arm, ongoing study that is further evaluating safety and effectiveness in 657 people treated with the device in the United States and Europe, which, at the time of approval, “show that there have been no unanticipated device- or drug-related adverse events,” the FDA said.

These studies also indicated that the safety of Lutonix DCB was comparable to conventional balloon angioplasty. The most common major adverse events included additional intervention, pain as a result of poor blood flow, narrowing of arteries that were not treated, chest pain, and abnormal growth of tissue.

Contraindications include women who are breastfeeding, pregnant, or plan to become pregnant; and men who plan to father children.

The company is required by the FDA to conduct two postapproval studies, the ongoing 5-year study of 657 patients, and a randomized, single-blind, multicenter study that will evaluate safety and effectiveness of the device in women in the United States, “due to differences in observed outcomes in this group as compared to outcomes for the general study population,” according to the FDA.

The device was reviewed at an FDA advisory panel meeting in June.

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