Devices

FDA Update on Paclitaxel-Coated Balloons/Stents

FDA has launched a new Web page about paclitaxel-coated balloons and paclitaxel-eluting stents that are approved to treat obstructed lesions in arteries of the legs. The page includes information about risks associated with these devices and ongoing agency efforts to work with manufacturers and investigators on additional clinical evidence development to assess the long-term device safety.

In 8/2019, FDA said that because of concerns about a late mortality signal in patients treated for peripheral artery disease with paclitaxel-coated balloons and paclitaxel-eluding stents, it was working with manufacturers on updated device labeling and clinical trial informed consent documents.

Last year, Swedish researchers said that an interim analysis of data from a clinical trial in which patients with peripheral artery disease received treatment with either paclitaxel-coated or uncoated endovascular devices found no difference in all-cause mortality between the groups in the incidence of death during one to four years of follow-up. The researchers reported in the New England Journal of Medicine that they published their results before the trial’s end to reduce patients’ and physicians’ concerns about the safety of paclitaxel-coated devices and because they considered the data to be important to support completion of ongoing trials investigating the efficacy of such devices in peripheral artery disease.

Meanwhile, FDA says it continues to evaluate the potential for increased long-term mortality after use of these devices to treat peripheral arterial disease in the femoropopliteal artery.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome