C. R. Bard announced that the US Food and Drug Administration (FDA) has granted approval for Lutonix 035 Drug Coated Balloon (DCB) Catheter for percutaneous transluminal angioplasty (PTA), after pre-dilatation, to treat Femoropopliteal Occlusive Disease.
The Lutonix 035 Drug Coated Balloon (DCB) can be used to treat de novo or restenotic lesions up to 150mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4mm-6mm.
C. R. Bard chairman and CEO Timothy Ring said the company is proud to offer first-of-its-kind innovation that expands therapy options for painful, progressive and debilitating disease.
"The Lutonix 035 DCB gives clinicians another option as they seek to provide prolonged patency to patients confronted with femoropopliteal occlusive disease," Ring added.
The approval was based on the results of LEVANT 2 pivotal study, a single-blind, randomized, 54-site study that enrolled all patients under one protocol.
C. R. Bard said the LEVANT 2 study demonstrated improved patency of the Lutonix 035 DCB compared to standard PTA. The study was assessed by Kaplan-Meier time-to-event analysis.
Since 2012, the Lutonix 035 DCB is available commercially in Europe.