The 2-year Levant 2 study data showed non-inferiority of the device and a trend towards superiority, compared to standard percutaneous transluminal angioplasty, in the treatment of peripheral artery disease, the company said.
“We want to thank the investigators involved in the Levant 2 trial for their authorship of this ground-breaking study. Publication of the study results in The New England Journal of Medicine demonstrates the high quality of the trial and the importance of the results,” CEO Timothy Ring said in a press release.
“The publication of these data in the prestigious New England Journal of Medicine reinforces not only the superior results for Lutonix 035 DCB compared to standard PTA, but also the rigor of the clinical trial. This should provide additional confidence to clinicians looking to use a drug coated balloon in treating PAD in the femoropopliteal arteries,” Bard senior veep of science, technology & clinical affairs Dr. John DeFord said in a prepared statement.
The study, released earlier this month, showed 78.7% composite safety scores at 2 years, primary patency of 58.6%, an 82% rate of freedom from target lesion revascularization and a 6.9% rate of death.
“Levant 2 followed a rigorous blinding protocol, which was designed to reduce bias in the results. In addition to superiority in primary patency, the paclitaxel-coated balloon used in the study also demonstrated sustained improvements in Rutherford category from baseline to 12 months, and improved patient-reported walking distance scores,” principal investigator Dr. Kenneth Rosenfield of Boston’s Massachusetts General Hospital said in prepared remarks.
Earlier this month, Bard said that the U.S. Centers for Medicare and Medicaid Services had improved the payment for Bard’s Lutonix drug-coated balloon catheter through the Medicare hospital outpatient prospective payment system.