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  • Regulatory NewsRegulatory News

    FDA Launches Probe into Drug-containing Balloons, Stents

    Paclitaxel-coated balloons and paclitaxel-eluting stents prompted a US Food and Drug Administration (FDA) letter to health care providers after a 2018 meta-analysis suggested an increased mortality rate in patients that received peripheral arterial disease (PAD) treatment with either of the device types. All-cause patient mortality rate at two years “significantly increased” and “increased further” after up to five years, following use of paclitaxel-coated balloons or p...
  • Regulatory NewsRegulatory News

    FDA Warns of Risks From Fluid-Filled Stomach Balloons to Treat Obesity

    The US Food and Drug Administration (FDA) on Thursday sent a letter to health care providers noting the receipt of dozens of reports for two different types of adverse events linked to fluid-filled intragastric balloons used to treat obesity.  “The first type of adverse event involves the fluid-filled intragastric balloon over-inflating with air or with more fluid (spontaneous hyperinflation) in patients’ stomachs, resulting in the need for premature device removal...
  • Fed Up With Medical Device Lag, Some Patient Seek Obesity Treatment in Canada

    A weight loss treatment available in Canada but not yet approved in the US is leading some patients to seek treatment across the border, reports The New York Times . The Times highlights the case of intragastric balloons, which were once available in the US before being taken off the market by its manufacturer, American Edwards Laboratories, in 1988. The devices are implanted in the stomach by way of the esophagus and filled with fluid. The device has since been appr...