Devices

Boston Scientific’s Watchman Gets Revised Label

FDA has expanded the approved labeling for Boston Scientific’s Watchman FLX Left Atrial Appendage Closure Device to include a 45-day dual anti-platelet therapy (DAPT) option as an alternative to the previous 45-day oral anticoagulation (OAC) plus aspirin for post-procedural treatment of patients with non-valvular atrial fibrillation. “This revised labeling provides physicians more flexibility to exercise their clinical judgment based on individual patient characteristics to determine the most appropriate post-procedural antithrombotic medication regimen,” the company says.

The revised label was supported by clinical evidence that included analyses spanning approximately 8,300 patients from the Left Atrial Appendage Occlusion (LAAO) Registry, which is part of the American College of Cardiology Foundation’s National Cardiovascular Data Registry, according to Boston Scientific. Additionally, real-world data submitted on the device included results of an analysis of more than 17,000 patients from LAAO Registry that “demonstrated no significant difference in rates of major adverse events at 45 days post implant, whether patients were discharged from the hospital on DAPT, a direct OAC and aspirin, or warfarin and aspirin,” it says.

On the safety side, the company submitted data it says shows low rates of adverse events and peri-device leaks through 45 days post implant.

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