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FDA Finds Paclitaxel Mortality Risk In Panel Lead-Up

 
• By Elizabeth Orr

Preview documents from the US FDA show the agency is aware of the mortality risk linked to paclitaxel-coated devices, but stop short of suggesting the devices be removed from the market.

FDA entrance sign 2016

An executive summary released by the US Food and Drug Administration ahead of next week’s cardiac devices advisory panel meeting on paclitaxel-coated cardiac devices recognizes an apparent increased death risk tied to the devices, but says more analysis is needed to further understand the issue.

The meeting, scheduled for 19 and 20 June, will continue a discussion of the safety of drug-eluting balloons and stents to treat peripheral arterial disease (PAD) that began after a...

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