NEJM Publishes Solid Results from C.R. Bard’s Levant 2 Study

C. R. Bard, Inc. today announced the publication of results from the Levant 2 study in the June 24 online issue of the New England Journal of Medicine.

According to the company, results from the study demonstrated “superior primary patency for Lutonix 035 Drug-Coated Balloon PTA Catheter (Lutonix DCB) over standard percutaneous transluminal angioplasty (PTA), as well as safety consistent with standard PTA balloons.”

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

In October last year, Lutonix 035 DCB was the first drug-coated balloon approved by the U.S. Food and Drug Administration (FDA). This approval followed a unanimous favorable recommendation from the FDA’s Circulatory Systems Devices Advisory Panel, which voted 9 to 0 on each element of safety, efficacy and benefit/risk.

The Levant 2 pivotal study 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, comparing Lutonix 035 DCB with standard PTA.

According to Kenneth Rosenfield, M.D., section head, vascular medicine and intervention, in the Division of Cardiology and Fireman Vascular Center at Massachusetts General Hospital, who was principal investigator for the study: “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.”

“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,” said John A. DeFord, senior vice president, science, technology and clinical affairs, C. R. Bard.

According to the American Heart Association, PAD affects nearly 8 million Americans with more than 50 percent of cases involving the superficial femoral and popliteal arteries. Globally, nearly 202 million patients suffer from this disease, which if untreated could increase the risk of heart attack or lead to death. Patients with PAD have reduced blood flow to their lower extremities due to narrowed arteries and carry the risk of amputations. Amputations or limb loss can cause huge physical and psychological burdens to patients and significant costs to the healthcare system.

Timothy M. Ring, chairman and CEO of Bard, commented: “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.”

C.R. Bard is based in Murray Hill, N.J.