Boston Scientific and C. R. Bard announced that Boston Scientific will distribute the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) in the US under a limited distribution agreement reached with Bard.
Terms of the agreement were not disclosed.
The Lutonix DCB is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel that is designed to decrease the incidence of restenosis and improve patency in patients with stenosed femoropopliteal vessels, often seen with peripheral artery disease.
Lutonix DCB was the first FDA-approved DCB in the US.
"Drug-coated balloons are a growing part of the treatment algorithm for peripheral artery disease and provide an alternative in the event a physician chooses not to place a permanent implant or scaffold," said Jeff Mirviss, president, Peripheral Interventions, Boston Scientific.
"We believe Bard’s Lutonix DCB is a great addition to our broad portfolio of vascular products."
"This agreement is designed to expand the reach of the Lutonix DCB and will afford more patients suffering from peripheral artery disease an opportunity to benefit from this innovative technology and clinically-proven therapy," said Steve Williamson, president of Bard Peripheral Vascular, Inc., one of Bard’s subsidiaries.
Peripheral artery disease (PAD) is a circulatory system disorder that results from a build-up of plaque in one or more of the arteries, most often in the legs.
As the disease progresses, plaque accumulation may significantly reduce blood flow through the arteries, resulting in pain and increasing disability, with severe cases often leading to amputation of the affected limb. It is estimated that 12-14 percent of the general population is affected by PAD.