Devices

No Higher Death Risk in Paclitaxel-Coated Devices: FDA

FDA says that as a result of additional data and analyses, it now no longer believes there is an excess mortality risk for paclitaxel-coated devices used to treat peripheral arterial disease. An agency 7/11 letter to healthcare providers reverses the announcement in a 1/17/2019 letter of a potential excess mortality risk.

The update letter says that in the last four years, additional data from pivotal trials have become available. It also says the agency has worked with device manufacturers and external stakeholders to develop the protocol and analysis plan for new data generation.

“Device manufacturers collaborated in an updated meta-analysis, which included additional studies, more complete vital status information, and longer-term follow-up compared to prior studies,” the letter says. “In these studies, patient follow-up ranged from two to five years, with data from most studies available out to five years. FDA clinicians and statisticians reviewed the study data and concluded that the updated meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.”

FDA says the issue applies to all models, lots, and unique device identifiers of paclitaxel-coated devices.

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