Devices

FDA Safety Issue with Paclitaxel-coated Balloons and Stents

FDA says it is evaluating recent information regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral arterial disease (PAD) in the femoropopliteal artery. “A recent meta-analysis of randomized trials published in the Journal of the American Heart Association (JAHA) suggests a possible increased mortality rate after two years in PAD patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with control devices (non-coated balloons or bare metal stents),” a 1/17 letter to physicians says. “The specific cause for this observation is yet to be determined.”

Paclitaxel-coated balloons and paclitaxel-eluting stents are intended to treat de novo or restenotic lesions in the femoropopliteal artery. In the U.S., paclitaxel-coated balloons are also marketed for treating stenotic lesions in dysfunctional native arteriovenous dialysis fistulae, the agency says. “While paclitaxel-coated stents have been approved for use in the treatment of coronary artery disease, no paclitaxel-coated balloons or paclitaxel-eluting stents are currently marketed for this use,” it says.

FDA says it is currently evaluating available long-term follow-up data to determine if there are any long-term risks associated with paclitaxel-coated products. “This review will focus on causes of death, the paclitaxel dose delivered, and patient characteristics that may impact clinical outcomes,” it says. Additional statistical analyses will be performed to clarify the presence and magnitude of any long-term risks.

FDA’s letter recommends that health care providers continue their surveillance of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents under current standard of care monitoring. In clinical decision-making, it says physicians should discuss the risks and benefits of all available treatment options for PAD.

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

Read more

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