BD Statement on FDA Circulatory System Devices Panel Regarding Paclitaxel-Coated Devices

FRANKLIN LAKES, N.J., June 20, 2019 — BD (Becton, Dickinson and Company) issued the following statement following the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting related to the potential increase in mortality associated with the use of paclitaxel-coated devices in patients with peripheral arterial disease (PAD) in the superficial femoropopliteal artery (SFA):

The panel discussed the benefits of paclitaxel-coated devices relative to the potential risks and noted strong evidence of benefit and recommended additional efforts to evaluate long-term safety. Additionally, BD presented its own data confirming that the benefits outweigh the risks for LUTONIX^® Drug-Coated Balloons (DCBs) in SFA. Over the past several months, BD has been working diligently to obtain all available patient follow up data and collaborating with FDA, professional clinical organizations and industry to investigate the important issue of DCB safety. BD continues to stand behind the safety of its LUTONIX^® DCBs and is committed to improving the quality of life for patients with PAD. BD will continue to collaborate with FDA, industry and professional organizations to collect and analyze data for the benefit of patients. To ensure patients with PAD continue to receive the best care possible, BD will continue to ensure physicians and patients have access to BD's broad range of treatment options for this serious disease.

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