Devices

FDA Warns on Paclitaxel-coated Devices’ Mortality Signal

FDA says that because of ongoing concerns about a late mortality signal in patients treated for peripheral artery disease in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents, it is working with manufacturers working on updated device labeling and clinical trial informed consent documents. In an 8/7 letter to physicians, the agency says it is also continuing to push for additional clinical evidence development for assessing the long-term safety of paclitaxel-coated devices.

The letter comes on the heels of a 6/19-20 meeting (see story) of the Circulatory System Devices Panel of the Medical Devices Advisory Committee that unanimously agreed data show a mortality signal. However, panel members were uncertain as to the signal’s magnitude, “primarily due to the small number of trials with five-years follow-up and high levels of missing data,” the agency said in a summary of the meeting.

Additionally, the letter provides recommendations for health care providers, such as “diligent monitoring of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents.” It also says for patients at “high risk for restenosis and repeat femoropopliteal interventions, clinicians may determine that the benefits of using a paclitaxel-coated device outweigh the risk of late mortality.”

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