Devices

Medtronic PMA Supplement for InterStim Micro/Leads

Medtronic has filed a PMA supplement for its InterStim Micro neurostimulator and InterStim SureScan MRI leads. InterStim Micro is a rechargeable, implantable sacral neuromodulation device for treating patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and fecal incontinence. The submission for the leads, which are intended to be used in future implants of the company’s recharge-free InterStim II system and rechargeable InterStim Micro system, is seeking “full-body 1.5 and 3 Tesla MRI conditional labeling,” Medtronic says, enabling patients to undergo imaging procedures that were not previously indicated under the current FDA approval for the InterStim II system.

InterStim Micro works by sending electrical impulses to the sacral nerves, “normalizing the connections between the brain, bladder and bowel,” according to the company. “It is 80% smaller than the current recharge-free InterStim II neurostimulator and could reduce the need for battery replacement surgeries due to its life of 15 years.”

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