Devices

FDA Panel Backs Abbott’s Absorbable Drug Eluting Stent

FDA’s Circulatory System Devices Panel has voted 9-0 to recommend approval of an Abbott PMA for the first fully absorbable drug eluting stent. Agency reviewers had determined that clinical data submitted showed that the device was not inferior to a traditional stent, according to a briefing document released in advance of the meeting.

The Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System is designed to dissolve within three years after being implanted. During the meeting, of implantation, after restoring blood flow to a blocked artery. While most stents are made of metal, the Absorb stent is made of a naturally dissolvable material. “The unique benefit of Absorb is that it opens the blockage like a metallic stent, but then goes away over time, allowing the artery to return to a more natural state,” the company says.

During voting, the panel agreed 9 to 1 that the device was safe as a treatment for coronary artery disease. On a separate question of whether there is reasonable assurance that the device is efficacious, the vote was 10 to 0 in favor.

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