Devices

FDA Clears Pantheris for In-stent Restinosis

FDA has cleared an Avinger 510(k) for a new clinical indication for the Pantheris image-guided atherectomy system — treating in-stent restenosis in the lower extremity arteries. Clearance was based on data generated from the INSIGHT trial, a prospective, global, single arm, multi-center study, according to the company. Key outcomes presented from the trial include:

82% luminal gain (increase in channel for blood flow) following the procedure
93% freedom from target lesion restenosis at 6 months post-procedure
89% freedom from target lesion restenosis at 12 months post-procedure
No amputations for the six- or 12-month cohorts of patients
0.96 mean ankle-brachial index at six months from a baseline of 0.69 pre procedure

The device features onboard image-guidance and a directional excision mechanism that allows the operator to target only the blockage and maximize the channel for restored blood flow while avoiding negative interactions with clearly delineated stent struts, the company says. Its proprietary Lumivascular technology also allows physicians to see from inside the artery during an atherectomy by using an imaging modality called optical coherence tomography.

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