Devices

FDA Expanded Approval for Medtronic Brain Stimulator

FDA has approved Medtronic’s Deep Brain Stimulation (DBS) therapy for use in people with Parkinson’s disease of at least four years duration and with recent onset of motor complications, or motor complications that are not adequately controlled with medication. The device was originally approved in 2002 for use in patients with advanced Parkinson’s disease. The company says it has demonstrated improvement in motor complications, quality of life, activities of daily living and reduction in medication usage in individuals with Parkinson’s.

The latest approval was based on data from the EARLYSTIM clinical study, which was published in the New England Journal of Medicine in 2013. The study found that patients treated with DBS therapy and “best medical therapy” (BMT) reported a mean improvement of 26% in their disease-related quality of life at two years, compared to a 1% decline in patients treated with BMT alone, Medtronic says. “In a study of patients with longer-standing motor complications, DBS patients’ quality of life improved 20% from baseline to six months compared to no improvement in the patients treated with BMT alone,” 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