FDA Approves First Drug Eluting Angioplasty Balloon

By Chuck Seegert, Ph.D.

The FDA has approved C.R. Bard’s Lutonix 035 Drug Coated Balloon (Lutonix DCB), a technology that may reduce restenosis of vessels treated by balloon angioplasty. This technology is the first of its kind to be approved for use in the femoral and popliteal arteries when they are stricken by Peripheral Artery Disease (PAD).

PAD is a disease that affects at least eight million patients each year in the United States, according to a recent press release from C.R. Bard. This disease reduces blood flow to the extremities and can lead to lower extremity amputation if not treated. Currently there are noninvasive and invasive methods of treating this disease, but limitations exist to current treatment methods that have led to the desire to develop something better.

“In line with Bard’s commitment to delivering products that improve patient care, we are proud to offer another Bard first-of-its-kind innovation that expands therapy options for this painful, progressive and debilitating disease,” said Timothy M. Ring, chairman and CEO of C.R. Bard, in the press release. “The Lutonix® 035 DCB gives clinicians another option as they seek to provide prolonged patency to patients confronted with femoropopliteal occlusive disease.”

The new device is used for percutaneous transluminal angioplasty (PTA), according to an announcement from the FDA. The procedure involves partially re-opening an artery with a standard balloon catheter. Then, the Lutonix DCB’s balloon, which is coated on its outer surface with the drug paclitaxel, is used to fully open the artery. The drug-coated balloon applies paclitaxel during the procedure and reduces the chances for restenosis of the artery after the operation.

In a European study that included 476 patients, the treatment with Lutonix DCB prevented restenosis in 65.2 percent of the procedures at 12 months, compared to the control group’s 52.6 percent, according to the FDA announcement.

“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, in the announcement. “The clinical data show that Lutonix DCB may be more effective than traditional balloon angioplasty at helping to prevent further blockage in the artery.”

In addition to balloon angioplasty, PAD can be treated using stents to reopen and maintain vessel patency. Recently, as discussed in an article on Med Device Online, the “Supera” stent from Abbott Laboratories was also approved by the FDA for PAD treatment.