Devices

FDA Advisers Reject J&J’s V-Wave Heart Shunt

An FDA advisory committee has voted unanimously against recommending approval of Johnson & Johnson’s V-Wave heart shunt for patients with advanced heart failure who have not responded to medication, citing insufficient evidence that the implant works.

The FDA’s circulatory system devices advisory panel voted 15-0 that the device failed to demonstrate effectiveness and that its overall benefit-risk profile did not support approval. On the question of safety, however, the panel was more divided, voting 9-6 that the device appeared adequately safe based on available data.

The implant is designed to help relieve pressure in the left atrium and improve symptoms in patients with refractory heart failure. While FDA advisory committees provide guidance, the agency is not required to follow their recommendations.

In a statement following the vote, a Johnson & Johnson spokesperson said the company is evaluating the panel’s feedback, particularly the call for additional clinical evidence.

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