The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB).
This is the first drug-coated balloon used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of peripheral artery disease (PAD).
PAD occurs when fatty material (plaque) builds up in the arteries that carry blood to the limbs, usually affecting the arteries in the legs. This causes hardening and/or narrowing of the arteries (atherosclerosis), limiting the flow of oxygen-rich blood to the body. People with PAD may experience symptoms, such as leg pain, or serious complications, including skin ulcers or gangrene. Existing options for treatment of PAD can include exercise, drug therapy, and other options within the artery, such as non-drug coated PTA, bare-metal or drug-eluting stenting, or surgical bypass.
The Lutonix DCB is a percutaneous transluminal angioplasty (PTA) catheter. The product has a balloon that is used to re-open the artery. The balloon is coated on its outer surface with the drug paclitaxel, which may help to prevent recurrent narrowing of arteries (restenosis) after the procedure. During the procedure, the artery is first partially opened with a traditional angioplasty balloon, without a drug coating. The Lutonix DCB is then used to fully open the narrowed portion of the artery and apply the drug to the artery wall. The Lutonix DCB may be used in arteries located in the thigh or the knee.
“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 demonstration of safety and effectiveness of the Lutonix DCB came from nonclinical testing, as well as three clinical studies.
One randomized, multi-center, European clinical study compared the safety and effectiveness of the Lutonix DCB to conventional balloon angioplasty. The study enrolled 101 participants who were randomly selected to be treated with Lutonix DCB or conventional balloon angioplasty. At the end of six months, 71.8 percent of participants treated with Lutonix DCB did not require additional PAD treatment compared to 48.6 percent of those treated with conventional balloon angioplasty.
In a separate pivotal, single blind, multi-center study conducted in the United States and Europe, researchers enrolled 476 participants who were randomly selected to be treated with Lutonix DCB or conventional balloon angioplasty. At the end of 12 months, 65.2 percent of participants treated with Lutonix DCB did not have a narrowing of the arteries (restenosis) compared to 52.6 percent of the control group.
A single-arm safety study involving the Lutonix DCB was also initiated and is ongoing. Researchers enrolled 657 participants in the United States and Europe. The primary objective of this safety study is to collect additional safety and effectiveness data on the Lutonix DCB in a large population. The available results at the time of product approval show that there have been no unanticipated device- or drug-related adverse events.
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.
The product is contraindicated (should not be used) in patients who cannot receive recommended drug therapy due to bleeding disorders; patients who cannot take or have known hypersensitivities to paclitaxel or structurally-related compounds; women who are breastfeeding, pregnant, or plan to become pregnant; or men intending to father children.
As part of the approval, the FDA is requiring the manufacturer to conduct two post-approval studies. One is a five-year post-approval study of 657 patients treated with the Lutonix DCB to further monitor safety and effectiveness. The second is a randomized, single blind, multi-center study which will assess the safety and effectiveness of the Lutonix DCB in women in the United States, due to differences in observed outcomes in this group as compared to outcomes for the general study population.
Lutonix DCB is manufactured by Lutonix, Inc. of New Hope, Minnesota.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.