Devices

FDA Clears Expanded Indication for Avinger PAD System

FDA has cleared an Avinger 510(k) for the Pantheris Lumivascular atherectomy system for use in Peripheral Artery Disease (PAD) patients for therapeutic and diagnostic purposes. The expanded indication clarifies that, in addition to treatment of PAD, Pantheris may be used by physicians to identify the vessel lumen and wall structures such as intima, internal elastic lamina, media, external elastic lamina and stent struts, as well as vessel morphologies such as calcium, thrombus, fibroatheromas, and necrotic cores, according to the company.

“Lumivascular technology in the Pantheris catheter allows physicians, for the first time ever, to see from inside the artery during a directional atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT,” Avinger says. “In the past, physicians have had to rely solely on X-ray as well as touch and feel to guide their tools while they try to treat complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices to treat PAD lesions using the guidance of OCT images generated from inside the artery. By relying upon OCT images as an adjunct to fluoroscopy, exposure to ionizing radiation may be reduced for healthcare workers and patients.”

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