Paclitaxel-Coated PAD Devices Under US FDA Scrutiny
The agency sent a letter to health-care providers stating that it is investigating reports of an elevated risk of death for patients starting two years after treatment with paclitaxel-coated balloons or paclitaxel-eluting stents. But FDA is not taking any regulatory action at this point.
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New US FDA analysis of paclitaxel-coated devices to treat peripheral arterial disease matches previous reports of an increased death risk tied to use of the devices. The agency is encouraging providers to look to other treatment options while analysis continues.
The Society for Cardiovascular Angiography and Interventions’ Vascular Disease Council says the recent meta-analysis finding a higher long-term mortality risk with paclitaxel-eluting peripheral devices can only be viewed as hypothesis-generating. The long-term risks of these devices should be investigated with patient-level data, SCAI argues. Several clinical data presentations at the recent LINC meeting in Leipzig showed comparable mortality rates with paclitaxel-eluting devices as comparable non-drug-eluting devices.
Results Recap: Medtronic Highlights Data To Contrast With Recent Meta-Analysis That Sparked Drug-Coated Balloon Scrutiny
This week's edition of Medtech Insight's Results Recap, the weekly roundup of major device trial-results from MedDeviceTracker, includes medical device trial results announced from Jan. 11 through Jan. 24. This week's list is dominated by results presentations from the Leipzig Interventional Course (LINC) in Leipzig, Germany, including trials of devices from Medtronic, Boston Scientific, Gore, Profusa, InspireMD, and Vessi.