BD Issues Statement on FDA Recommendations Regarding Paclitaxel-Coated Devices

August 13, 2019—BD, the manufacturer of the Lutonix paclitaxel-coated balloon catheters for percutaneous transluminal angioplasty, issued a response to the FDA’s “thoughtful, updated recommendations” in its updated statement. The FDA statement, issued on August 7, addressed the increased mortality potentially associated with the use of paclitaxel-coated balloons and paclitaxel-eluting stents for the treatment of peripheral artery disease (PAD). The FDA statement summarized the analysis of the information presented at the June public meeting of the Circulatory System Devices Panel of the FDA Medical Devices Advisory Committee.

BD noted that although 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 with uncoated devices, concluding that the benefits of paclitaxel-coated devices (eg, reduced reinterventions) should be considered in high-risk patients for restenosis and repeat femoropopliteal interventions.

BD commented in its press release, “We believe that Lutonix drug-coated balloons (DCBs) should be a part of the optimal medical therapy for PAD and, like the FDA, the benefits of DCB use should be considered for high-risk patients along with potential risks (eg, late mortality). We continue to collaborate with the FDA to update product labeling, which will include our investigation, as well as assess additional long-term DCB data.”

Furthermore, the company stated, “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 health care providers.”

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