Devices

FDA Approves Impella Devices for Treating Cardiogenic Shock

FDA has approved an Abiomed PMA for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps to provide treatment of ongoing cardiogenic shock. “In this setting, the Impella heart pumps stabilize the patient's hemodynamics, unload the left ventricle, perfuse the end organs and allow for recovery of the native heart,” the company says. Previously, the devices were approved for high risk percutaneous coronary intervention (PCI), or protected PCI.

The Impella devices are intended for short-term use (less than four days for the Impella 2.5 and Impella CP and less than six days for the Impella 5.0 and Impella LD) and indicated for treating ongoing cardiogenic shock that occurs immediately (less than 48 hours) following acute myocardial infarction or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures with or without an intra-aortic balloon pump, according to the company. The devices are designed to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function. The product labeling also allows for the clinical decision to leave the devices in place beyond the intended duration of four to six days due to unforeseen circumstances.

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