Lutonix 035 Gets FDA Approval

The US Food and Drug Administration (FDA) has approved a new angioplasty balloon catheter for the treatment of vascular disease.

The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter is the first drug-coated balloon approved for use to re-open arteries in the thigh and knee when those arteries are narrowed as a result of peripheral artery disease, the agency said. Lutonix is based in New Hope, MN.

The balloon is coated on the outside with the drug paclitaxel, which may prevent recurrent narrowing of the arteries. The Lutonix DCB is used in combination with a traditional angioplasty balloon. The traditional balloon is inserted first. The Lutonix DCB is inserted next, and used to apply the drug to the artery wall and then to fully open the artery.

“Peripheral artery disease can be quite serious, said William Maisel, MD, MPH, deputy director for science and chief scientist at 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 Lutonix data came from nonclinical testing and three clinical trials, according to FDA. Those trials showed patients receiving the Lutonix DCB had lower rates of restenosis after several months.