Harvard Heart Letter

Drug-coated balloon for opening leg arteries gets FDA approval

When an artery in the leg narrows because of a buildup of fatty plaque, it's called peripheral artery disease, or PAD. Physicians now have a new option for treating PAD: a drug-coated balloon just approved by the FDA. The first of its kind, the Lutonix DCB features a balloon coated with the drug paclitaxel. Originally derived from the yew tree and used to treat cancer, paclitaxel helps prevent cell overgrowth. It is also used in drug-coated stents, the tiny, wire-mesh tubes used to prop open arteries in the heart.

During the Lutonix DCB procedure, a doctor threads a tiny, balloon-tipped tube through a blood vessel in the upper leg to the blocked area in the artery (a procedure known as angioplasty). The blocked area is partially opened with a traditional angioplasty balloon. Then, the Lutonix is used to fully open the narrowed artery and apply the drug to the artery wall. The device can be used in arteries in the thigh or the knee. Studies suggest that the new device is more effective than traditional angioplasty alone for keeping an opened artery from closing back up.

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