FDA advisory seeks femoral closure device data:
This article was originally published in Clinica
The US FDA has issued a public health advisory seeking reports of adverse events concerning femoral artery closure devices. As predicted in last week's Clinica (see Clinica No 879, p 11), the US regulator claims there have been "reported complications related to these devices" and lists haematoma, retroperitoneal bleeding, pseudoaneurysm, late bleeding and, infrequently, death. The letter asks for reports of adverse events related to devices such as those from Perclose, St Jude Medical and Datascope, although it concedes that such adverse events also occur with manual compression closure. Perclose is brand leader, with an estimated 25% of the market.
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