Drugs

FDA Safety Alert on Abbott Absorb Vascular Scaffold

An FDA safety alert has advised health care providers that Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) has seen an increased rate of major adverse cardiac events compared to the company’s metallic Xience drug-eluting stent. BVS, which is implanted during an angioplasty procedure, is used to open heart blood vessels blocked by scar tissue in order to increase blood flow.

The agency says its initial review of two-year data from the BVS pivotal clinical study (the ABSORB III trial) shows an 11% rate of major adverse cardiac events (e.g., cardiac death, heart attack, or the need for an additional procedure to re-open the treated heart vessel) in patients treated with the BVS at two years, compared with 7.9% in patients treated with Xience drug-eluting stent. “This study also shows a 1.9% rate of developing blood clots (thrombosis) within the BVS versus 0.8% within the Xience stent at two years,” it says. “These observed higher adverse cardiac event rates in BVS patients were more likely when the device was placed in small heart vessels.”

The safety alert recommends that health care providers follow the instructions for target heart vessel selection (e.g., avoiding BVS use in small heart vessels) and optimal device implantation that are included in the BVS physician labeling.

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