FDA approves first drug-coated balloon catheter

October 10, 2014

FDA approved the Lutonix 035 Drug Coated Balloon (DCB) Catheter (Bard) for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150 mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4 mm to 6 mm.

FDA approved the Lutonix 035 Drug Coated Balloon (DCB) Catheter (Bard) for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150 mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4 mm to 6 mm.

Lutonix 035 DCB is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and uses standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease (PAD) in the femoropopliteal arteries.

It is the first and only FDA-approved DCB in the United States.

“This is another therapy that may improve outcomes in patients with coronary artery disease who need some type of intervention,” said FormularyWatch advisor James M. Wooten, PharmD, associate professor, department of medicine, section of clinical pharmacology, University of Missouri-Kansas City.

“It will be interesting to see how this intervention compares with stenting and if the need for continuous antiplatelet therapy is necessary with this procedure as it is with stents coated with specific immunosuppressive compounds,” Dr Wooten said.

The approval was supported by results of the LEVANT 2 pivotal study, a global, prospective, single-blind, randomized, 54-site study (42 sites in the United States and 12 in Europe) that enrolled all patients under one protocol. At 1 year, the LEVANT 2 study demonstrated improved patency of the Lutonix 035 DCB compared to standard PTA: 73.5% vs. 56.8%, P<.001 by Kaplan-Meier time-to-event analysis. It also demonstrated clinical benefits of sustained improvement in Rutherford Class and improved walking distance scores. The LEVANT 2 study followed a rigorous blinding protocol designed to reduce bias in the results to accurately and scientifically assess and compare the long-term performance of key clinical measures. The LEVANT clinical program, which includes registry data, enrolled more than 1,000 patients and demonstrated robust safety of the device comparable to PTA, including the same low rate of distal embolic events and rate of reintervention for thrombotic events.

The American Heart Association (AHA) estimates that PAD, a life-threatening condition, affects at least 8 million Americans by narrowing arteries and reducing blood flow to the limbs. Patients with PAD in the femoropopliteal arteries are at risk for lower-extremity amputation, particularly in people over aged 50 years. Successful treatment of PAD in the femoropopliteal arteries requires improved blood flow (patency) for longer periods of time. While there are both non-invasive and invasive treatment options for these arteries available, each has associated limitations. PTA is currently the first-line, standard-of-care treatment for PAD, according to the American College of Cardiology and AHA 2011 guidelines; however, it is limited by its relative lack of long-term patency.

The Lutonix 035 DCB has been available commercially in Europe since 2012.

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