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Shifting trial design and missing data, plus little evidence of benefit, worked against the paclitaxel-coated balloon, panelists and US FDA speakers said.
If approved, the device will be the first drug-coated balloon indicated specifically for use in arteries below the knee.
The cybersecurity concern could allow invaders to shut down certain automated pump functions, BD says.
The global infusion drug delivery market continues to be driven by the rising prevalence of chronic disease and associated obesity, coupled with a growing aging population. Technological advancements such as less invasive pumps, needlestick prevention features and miniaturization have also supported the growing demand, but obstacles such as safety and security issues remain. According to a new report by Meddevicetracker, the global market for infusion pumps and disposables will reach $9.9bn by 2022, a CAGR of 6.4% from 2017. This article takes an in-depth look at the overall infusion pumps market, and dives deeper into the three fastest-growing segments – insulin, enteral and disposable pumps – highlighting the key players and competitive landscape.