Twelve-Month Data Presented From Bard's Lutonix Global Real-World Registry

October 13, 2015—Bard Peripheral Vascular announced that 12-month results from the Lutonix Global Real-World Registry were presented at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium being held October 11–15 in San Francisco, California. 

The registry is evaluating the company’s Lutonix 035 drug-coated balloon (DCB) catheter in the treatment of patients with symptomatic femoropoliteal peripheral artery disease (PAD). In the study, the Lutonix 035 DCB demonstrated a freedom from target lesion revascularization (TLR) rate of 94.3% in femoropopliteal arteries at 12 months in 631 patients. Additionally, interim data from 170 patients who were early enrollees demonstrated a freedom from TLR rate of 93% at 24 months.

In a company’s press release regarding the presentation, Prof. Dierk Scheinert, MD, Head of Department of Interventional Angiology at the University of Leipzig in Germany, commented, “The final 12-month results of the Lutonix Global Registry demonstrated how real-world PAD patients with complex and long lesions can benefit from this DCB technology without leaving metal behind. Also encouraging are the interim 24-month results which suggest durable benefits of the Lutonix DCB.”

In June 2015, the company announced the publication of the 1-year results from the randomized LEVANT 2 pivotal study and the presentation of the 2-year data from LEVANT 2. One-year data were published by Kenneth Rosenfield, MD, et al in The New England Journal of Medicine (2015;373:145-153). The 2-year data from LEVANT 2 were presented at the Society of Vascular Surgery’s Vascular Annual Meeting in Chicago, Illinois, in June. Both the 1- and 2-year results demonstrated superior primary patency for the Lutonix 035 DCB catheter over standard percutaneous transluminal angioplasty in patients with symptomatic femoropoliteal PAD.