Drugs

FDA OK’s Labeling Change on Heart Failure Device

FDA has approved a labeling modification on Impulse Dynamics’ Optimizer Smart medical device, allowing the removal of a “normal sinus rhythm (NSR)” limitation from the indications for use statement. “Since patients are no longer required to be in NSR at the time of Optimizer implant, heart rhythm does not impose any restrictions on patients eligible for the Optimizer implant, the company says.

The implant is intended to treat patients experiencing moderate to severe congestive heart failure symptoms even after previous medical treatment, according to the company. The device operates by delivering timed electric pulses called cardiac contractility modulation (CCM) therapy.

FDA’s decision was based on data from a long-term clinical study and a registry featuring 503 patients in the European Union, which compared the outcomes of those with atrial fibrillation treated with CCM therapy to a cohort treated with CCM that did not have A-fib, according to the company. “Both groups exhibited positive results, and no safety issues related to heart rhythm were identified,” it says.

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