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BD statement on FDA recommendations

BD appreciates the Food and Drug Administration’s (FDA) thoughtful, updated recommendations regarding the use of paclitaxel-coated devices following the Advisory Committee meeting of the Circulatory System Devices Panel in June. While the Panel concluded that a late mortality signal was present, the FDA and the Panel recognized the benefits of these devices and agreed that the magnitude of the signal should be interpreted with caution due to multiple limitations in the available data.

Specifically, the FDA communicated that paclitaxel-coated devices improve blood flow to the legs and decrease the likelihood of repeat procedures to reopen blocked blood vessels compared to uncoated devices, concluding the benefits of paclitaxel-coated devices (e.g., reduced reinterventions) should be considered in high risk patients for restenosis and repeat femoropopliteal interventions.

The company believes that Lutonix drug-coated balloons (DCB) should be a part of the optimal medical therapy for peripheral arterial disease (PAD) and, like the FDA, the benefits of DCB use should be considered for high-risk patients along with potential risks (e.g., late mortality). The company continues to collaborate with the FDA to update product labeling, which will include investigation, as well as assess additional long-term DCB data.

BD stands behind the safety of its Lutonix DCB and is committed to improving the quality of life for patients with PAD. To ensure patients receive the best care possible, BD’s broad range of treatment options for this serious disease will continue to be available for healthcare providers.

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