Devices

Advisors Back Cordis Stent-Graft Device

Members of the FDA Circulatory System Devices Advisory Committee voted 11-4 on 6/12 to recommend that the agency give premarket approval to Cordis’ Incraft stent-graft device for abdominal aortic aneurysms. FierceBiotech reports that the device is deployed through the artery and opened to seal and relieve pressure where the aorta splits to supply blood to the legs. It says that rates of subsequent stent fractures and endoleaks led the agency to deny approval of the device and request more clinical information in 7/2015, 4/2016, and 7/2017 letters to the company.

Cordis said that data collected following the FDA rejections found no subsequent injuries, symptoms, or clinical consequences observed following a stent fracture, and no secondary interventions required as a result, over more than four years of monitoring.

FDA reviewers said that fractures were found in 10% of study patients, with additional fractures and propagations being reported as follow-up time increased. The company said it believed the totality of the evidence supported device approval. The agency reviewers also pointed to a higher-than-normal frequency of type II endoleaks, the most common and least dangerous kind, caused by largely benign, retrograde flows of blood from branching arteries.

“Most studies report declining percentages over time with around 10% for longer-term follow-up as compared to the more stable rates of around 36-45% in the study,” the reviewers said. In addition, they reported, 15.3% of study participants say their aneurysm expand following the procedure, with a majority of the cases found to be likely attributable to type II endoleaks. Other studies of similar devices have reported percentages between 4% and 12%, the reviewers said.

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