Devices

Safety Alert on Stryker Ankle Replacement

FDA has issued a safety alert on Stryker’s Scandinavian Total Ankle Replacement device due to a higher than expected risk of the device’s polyethylene (plastic) component breaking as early as three to four years after implantation. “Fracture of the plastic component of the STAR Ankle may lead to surgery to repair or replace the device,” the alert says.

The device is indicated for use as a non-cemented total ankle prosthetic to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis. It comprises a tibial plate, a mobile-bearing polyethylene component, and a talar component, which is designed to allow for some of normal ankle mobility and function, FDA says.

“The FDA believes the STAR Ankle remains appropriate for certain patient populations, such as older patients with lower activity levels,” the alert says. “Based on the additional medical literature and real-world evidence, patients with more active life styles, osteoarthritis (disease where the protective joint tissue breaks down and causes pain and swelling), or age younger than 55 years old may have a higher than expected risk of the plastic component breaking.”

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