Lutonix rejection exacerbates Becton Dickinson’s peripheral woes

With sales of paclitaxel-coated balloons under threat after analyses concluded that they are unsafe when used in the femoropoliteal artery, just above the knee, Becton Dickinson could have done with an additional FDA approval in a different setting. Unfortunately the agency has not complied, knocking back the company’s application for its Lutonix device in below-the-knee procedures. There has been no suggestion that the device is unsafe in this indication, with the FDA saying that the PMA submission is not acceptable in its current form; BD says the application remains active. Comparing current sales forecasts as compiled by EvaluateMedTech with those from mid-June, before the FDA convened a panel to examine paclitaxel-coated devices, shows that Becton Dickinson is now forecast to reap $1.8bn from its peripheral vascular devices in 2024 – $200m lower than had been forecast two months ago.

Becton Dickinson’s peripheral interventional business
    2018 2020e 2022e 2024e CAGR
Current forecasts Global sales ($bn) 1.0 1.4 1.6 1.8 +9%
       % of total company sales 7% 8% 8% 8%  
Forecasts from mid-June Global sales ($bn) 1.0 1.5 1.8 2.0 +11%
       % of total company sales 7% 8% 9% 9%  
Source: EvaluateMedTech.

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