January 29, 2020

Interim Long-Term Safety Data Presented for BD’s Lutonix 014 DCB in BTK Arteries

January 29, 2020—BD (Becton, Dickinson and Company) announced the presentation of interim findings from the Lutonix BTK investigational device exemption trial of the company’s Lutonix 014 drug-coated balloon (DCB) versus standard balloon angioplasty for treatment of below-the-knee (BTK) arteries. The data were presented at LINC 2020, the Leipzig Interventional Course held January 28–31 in Leipzig, Germany.

According to the company, the data show positive safety results at 3 years for freedom from mortality, freedom from major amputation, and amputation-free survival.

The Lutonix BTK clinical study is a prospective, global, multicenter, single-blind, randomized (2:1) controlled trial comparing the Lutonix 014 DCB to percutaneous transluminal angioplasty (PTA) for the treatment of narrowed or obstructed BTK arteries. The safety endpoints were assessed using a Kaplan-Meier (K-M) analysis through 36 months for the intent-to-treat population, with 70% of patients having completed 3-year follow up at the time of analysis.

BD reported that at 1,095 days comparing DCB versus PTA, there is no significant difference in freedom from mortality (81% vs 81%; P = .946), freedom from major amputation (95.5% vs 93.8%; P = .268), or amputation-free survival (77.8% vs 77.8%; P = .495).

The Lutonix 014 DCB demonstrated statistically improved primary efficacy at 6 months when compared to PTA by K-M analysis, with K-M curves merging at 1 year. There were no statistical differences in safety or efficacy beyond 6 months in this interim analysis. Additionally, the Lutonix BTK clinical study results showed that the Lutonix 014 DCB versus PTA provided statistically significant efficacy outcomes at 6 months, with no observed safety issues out to 3 years.

The Lutonix 014 DCB has been commercially available in Europe, Canada, and Australia for the treatment of the BTK arteries in patients with critical limb ischemia since 2013. The product is an investigational device in the United States, advised BD.


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