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September 21, 2016
Two-Year Outcomes Reported From Bard's Lutonix Global Real-World Registry
September 22, 2016—Bard Peripheral Vascular announced that the final 24-month results from the Lutonix Global Real-World Registry were presented at VIVA 16, the Vascular InterVentional Advances meeting held September 18–22 in Las Vegas, Nevada.
According to the company, the registry, including a subgroup of patients with long femoropopliteal lesions (> 140 mm), is evaluating treatment with the Lutonix 035 drug-coated balloon (DCB) percutaneous transluminal catheter.
In the registry, the Lutonix 035 DCB demonstrated a 90.3% freedom from target lesion revascularization (TLR) at 24 months by Kaplan-Meier time-to-event analysis for the overall study population of 527 patients. In the long lesion subgroup of 106 patients, the freedom from TLR was 89.4%. A premarket approval supplement for use of the device in this subgroup population is currently under review with the US Food and Drug Administration, advised the company.
In Bard’s announcement, James Benenati, MD, commented, “These 24-month outcomes show the therapeutic durability and safety of the Lutonix DCB in challenging real-world patients with complex femoropopliteal artery lesions.” Dr. Benenati is Medical Director of the Peripheral Vascular Laboratory at Miami Cardiac & Vascular Institute in Miami, Florida.
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