Lutonix

The LUTONIX® DCB formulation was designed for the optimal balance of safety and efficacy with a purposeful low dose and appropriate excipient, which together allow for effective transfer of drug to the vessel wall while minimizing downstream effects. The LUTONIX® DCB offers the most clinical indications on the U.S. Market.1 The LUTONIX® DCB offers... the largest DCB product offering, with the lowest DCB profile, on the U.S. market.1 LUTONIX® is the first and only DCB to receive FDA approval on a 0.018 wire configuration. LUTONIX® is the first and only drug coated balloon with longer 220 mm length balloons on an all-5F platform. LUTONIX® is shown to enable longer AV fistula function due to increased time to first reintervention compared to standard angioplasty. LUTONIX® is the first DCB to offer sizes 8-12mm in diameter. LUTONIX® is the first DCB to receive indication for long lesions that are up to 300mm. LUTONIX® is the only DCB on the U.S. market with all sizes 5F, designed to minimize the size of the access site. In August 2019, the U.S. Food and Drug Administration (FDA) issued an updated letter to health care providers noting an increased risk in late mortality (2-3 years post-treatment) with paclitaxel-coated devices when used to treat peripheral arterial disease in the femoropopliteal artery as compared with the use of non-drug coated devices. There is uncertainty regarding the magnitude and mechanism for the increased late mortality risk, including the impact of repeat paclitaxel-coated device exposure. Physicians should discuss this late mortality signal and the benefits and risks of available treatment options with their patients. BD will continue to work collaboratively with FDA and industry for additional safety data collection and inform labeling as appropriate. These communications as well as information about the FDA Panel meeting can be found at: ...Read More