FDA, Researchers Flag Safety Problems With Vena Cava Filters
This article was originally published in The Gray Sheet
Executive SummaryFDA is warning clinicians about long-term use of certain retrievable embolism-protection filters after receiving nearly 1,000 adverse event reports about the devices
You may also be interested in...
Two patients who say they were injured by vena cava filters made by Cook and Boston scientific filed suit against the manufacturers in Kentucky federal court earlier this month. The suits build on safety concerns about the filters previously circulated by FDA and researchers.
Decision analysis tools will be put into practice as part of the device center’s priority “innovation pathway” for breakthrough devices and in a pilot program focused on obesity devices. The techniques may allow for shorter development and review cycles, among other benefits, CDRH says.