The Lutonix 035 drug-coated balloon (DCB) is made by Minnesota-based Lutonix, which C.R. Bard purchased in December 2011 for an upfront $225 million with $100 million due upon FDA approval of the device. The product has been available in Europe since 2012. The greenlight comes after an FDA panel unanimously recommended the product’s approval in June.

In the United States, this is the first drugcoated balloon used to reopen arteries in the thigh and knee when they become narrowed or blocked because of peripheral artery disease (PAD), according a news release. People with PAD suffer leg pain, and may lead to skin ulcers and gangrene.

“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,” Timothy M. Ring, chairman and CEO of C. R. Bard, said in a news release. “The Lutonix 035 DCB gives clinicians another option as they seek to provide prolonged patency to patients confronted with femoropopliteal occlusive disease.” 

The drug-eluting balloon is coated externally with paclitaxel, a drug that has the potential to help prevent the arteries from being blocked again after the procedure.

During the procedure, the blocked artery is first partially opened with a traditional angioplasty balloon sans the drug. Thereafter, the Lutonix DCB is used to fully open the narrowed portion of the artery. This allows the drug to be applied to the artery wall.

In a pivotal, single-blind, randomized multicenter study conducted in the United States and Europe that enrolled 476 patients, 65.2% of participants treated with Lutonix DCB did not have a narrowing of the arteries (restenosis) compared with 52.6% of the control group after 12 months.

By : Arundhati Parmar，<MDDI>