Devices

FDA View on Paclitaxel-Coated Devices Updated

Writing in a New England Journal of Medicine Perspective article, three CDRH staffers review new studies on the safety of paclitaxel-coated devices (PCDs) used to treat atherosclerotic peripheral arterial disease (PAD) and call for ongoing data collection. The article discusses questions that have been raised about the devices’ safety since 2018 and an 8/7/2019 updated agency letter to healthcare providers reviewing the strengths and limitations of a signal of a late increase in mortality associated with PCDs.

The authors cite interim results from the Swedish Drug Elution Trial in Peripheral Arterial Disease that “provide important and reassuring information on PCDs used to treat femoropopliteal disease.”

The article says FDA’s current position is that because of the demonstrated short-term benefits of the devices and the limitations of the available data, clinical studies of the devices should continue and should collect long-term mortality data. It says FDA now routinely reviews longer-term data for PCDs for which market authorization is being sought when they are intended to treat patients with PAD and the agency requests that trials capture information on adjunctive antithrombotic therapy and medications indicated for patients with atherosclerosis.

“The use of a PCD may be the best treatment for some patients, particularly those judged to be at particularly high risk for restenosis and repeat femoropopliteal interventions,” the CDRH staffers conclude. “Additional data are needed to further refine optimal treatment strategies for patients on the basis of their risk profile for restenosis incorporating patient-specific factors … and lesion-specific factors.”

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