FDA Panel Votes No On BD's Balloon For Below The Knee
Shifting trial design and missing data, plus little evidence of benefit, worked against the paclitaxel-coated balloon, panelists and US FDA speakers said.
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If approved, the device will be the first drug-coated balloon indicated specifically for use in arteries below the knee.
The US body says it wants to encourage labs to use newer, faster alternatives that can also detect other pathogens.
Patients in Canada and the US are suing Philips over issues related to the company’s recent recall of CPAPs, BiPAPs, and mechanical ventilators.