LEVANT 2 Analysis Shows Significantly Improved Primary Patency With Proper Wall Apposition for Bard's Lutonix 035 DCB

November 5, 2014—Principal investigator Kenneth Rosenfield, MD, reported new patency data from the LEVANT 2 clinical trial showing that proper angioplasty technique can significantly improve outcomes of drug-coated balloon (DCB) treatment. Dr. Rosenfield, who is from Massachusetts General Hospital in Boston, Massachusetts, presented the findings at the VIVA 2014: Vascular Interventional Advances meeting in Las Vegas, Nevada.

LEVANT 2 is 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 to study the Bard Peripheral Vascular, Inc.’s Lutonix 035 DCB catheter. Results from LEVANT 2 supported US Food and Drug Administration (FDA) approval of the device, which Bard announced on October 10, 2014.

In LEVANT 2, the Lutonix 035 DCB demonstrated an approximately 30% improvement in 12-month primary patency as compared to standard balloon angioplasty for the treatment of femoropoplital artery stenosis. 

The post-hoc analysis presented at VIVA 2014 showed that when the DCB achieved proper wall apposition (balloon-to-artery ratio > 1), the device’s 12-month primary patency improvement versus percutaneous transluminal angioplasty more than doubled, to 66%. The Bard Lutonix 035 DCB achieved 80% primary patency with no downstream embolic events.

Bard’s Lutonix 035 DCB catheter was approved for percutaneous transluminal angioplasty, after predilatation, 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 to 6 mm. The Lutonix 035 device will be the first FDA-approved DCB available in the United States. In Europe, the Lutonix DCB has been commercially available since 2012.