Devices

Medtronic Arctic Front Cardiac Cryoablation Expanded OK

FDA has approved a Medtronic PMA supplement for expanded approval for its Arctic Front Cardiac Cryoablation Catheters to include treating recurrent symptomatic paroxysmal atrial fibrillation (episodes that last less than seven continuous days) as an alternative to antiarrhythmic drug (AAD) therapy as an initial rhythm control strategy. The expanded indication is based on results from the STOP AF First, study that demonstrated superior efficacy of the Medtronic cryoablation procedure for preventing atrial arrhythmia recurrence compared to the use of AAD therapy, the company says.

FDA in 2012 approved the device for treating paroxysmal atrial fibrillation. The device features the company’s EvenCool Cryo Technology, which optimizes coolant delivery inside the balloon. “As a result, the larger, more uniform cold surface reduces the effort needed to isolate the pulmonary veins, the target of most AF ablation procedures, and improves physicians’ ability to treat patients with complicated anatomies compared to the original Artic Front CryoAblation System,” the company said at the time.

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