Devices

UK Caution on Some Balloons, Stents

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) says doctors should not use paclitaxel drug-coated balloons or drug-eluting stents in routine treatment of patients with intermittent claudication until further notice, as the potential mortality risk outweighs the benefits. An agency medical device alert says use of the balloons and stents in patients with critical limb ischemia remains an appropriate option as the benefits may outweigh the risks because such patients generally have a higher risk of irreversible ischemic damage resulting from restenosis, and a lower life expectancy.

The notice says a 12/2018 meta-analysis published in the Journal of the American Heart Association highlighted a statistically significant all-cause mortality from two to five years post-treatment, compared with patients treated with plain balloons or bare-metal stents. “These findings raised significant concerns on their use in routine clinical practice and clinical trials,” MHRA says. The agency formed an independent expert advisory group that recently made recommendations.

FDA issued a similar safety alert earlier this year.

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