Six-Month LEVANT 2 Data Presented For Bard's Lutonix Drug-Coated Balloons

October 30, 2013—Bard Peripheral Vascular, Inc. (Tempe, AZ) announced 6-month results from the LEVANT 2 trial of the company's Lutonix drug-coated balloon for the treatment of peripheral arterial disease. LEVANT 2 coprimary investigator Kenneth Rosenfield, MD, presented the data at the Transcatheter Cardiovascular Therapies (TCT) conference in San Francisco, California. Dr. Rosenfield is Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital in Boston, Massachusetts.

According to Bard, the trial's 6-month follow-up results from randomized patients treated with the Lutonix drug-coated balloon demonstrated safety comparable to uncoated balloons (94% vs 94.1%) and superior primary patency (92.3% vs 82.7%; P = .003) by Kaplan-Meier time-to-event analysis.

Dr. Rosenfield noted that the LEVANT 2 study, conducted under an investigational device exemption, was rigorously designed to reduce bias in the results in order to accurately and scientifically assess and compare the long-term performance of the treatment modalities alone. The LEVANT 2 clinical trial excluded patients who received a stent after initial predilatation of the vessel from the study population. Also, to reduce the potential introduction of bias into the subjective clinical decision for revascularization, protocol required the clinical assessment to be performed by a physician blinded to the treatment group and the Doppler patency measure, reported the company.