Bard has announced the presentation of the final 24-month results from the Lutonix Global Real-World Registry at the Vascular Intervention Advances (VIVA) 2016 meeting (18–22 September, Las Vegas, USA).
These results are the first reported final 24-month outcomes for “real-world” registry data for drug-coated balloon percutaneous transluminal angioplasty catheters. The registry includes a subgroup of patients with long femoropopliteal lesions (>140mm) treated with the Lutonix 035 drug-coated balloon. A premarket approval supplement for use in this subgroup population is currently under review with the US Food and Drug Administration.
In this registry study, the Lutonix 035 demonstrated a freedom from target lesion revascularisation at 24 months by Kaplan-Meier time-to-event analysis of 90.3% for the overall study population of 527 patients and 89.4% for the long lesion (>140mm) subgroup of 106 patients.
James Benenati, medical director of the Peripheral Vascular Laboratory at Miami Cardiac & Vascular Institute, USA, commented, “These 24-month outcomes show the therapeutic durability and safety of the Lutonix drug-coated balloon in challenging real-world patients with complex femoropopliteal artery lesions.”
Timothy M Ring, chairman and chief executive officer, commented, “The Lutonix Global Registry continues to generate strong real-world evidence, confirming the sustained effectiveness of the Lutonix drug-coated balloon, which provides clinicians with an alternative to treat patients who have peripheral artery disease in femoropopliteal arteries.”