Latest Medicare Data Suggests No Heightened Death Risk For Paclitaxel-Coated Devices
A large study of US Medicare patients treated with either drug-coated stents, balloons or other equivalent devices shows a similar morbidity rate in both groups, further contradicting a 2018 literature review that warned of higher death rates in patients treated with paclitaxel-coated devices.
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The SAFE-PAD study, which looked at data from more than 168,000 Medicare beneficiaries, found a slightly lower death rate in patients treated with drug-coated balloons and stents than those who were not.
For Second Time This Month, Medtronic Announces Class I FDA Recall Related To HeartWare System Component
Medtronic, Baxter and BD are all facing recalls, with Medtronic finding yet another issue with HeartWare HVAD systems. Separately, the FDA put a Baxter respiratory device recall into Class I, and BD announced a recall on intraosseous devices.
US regulators plan to hold a public meeting later this year to address concerns the devices are less accurate for people with darker skin tones.