Devices

Abbott PMA for Absorbable Stent Shows Non-inferiority: FDA

An Abbott PMA for the first fully absorbable drug eluting stent contains clinical data showing the device was not inferior to a traditional stent, according to an FDA briefing document released in advance of a 3/15 Circulatory System Devices Panel meeting. While clinical data for Abbott’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System met the criterion for non-inferiority to the company’s Xience stent, the rates for target vessel myocardial infarction and stent thrombosis were numerically higher in the BVS group vs. the Xience group, the agency says. The absolute difference of the target lesion failure rate between treatment groupswas 1.71% in favor of the Xience group. FDA plans to ask panel members to vote on whether the data demonstrate adequate evidence of clinical non-inferiority to support approval.

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