Devices

Boston Scientific’s Spinal Cord Stimulator Wins 50% Pain Cut OK

FDA has approved an expanded indication for Boston Scientific’s WaveWriter Spinal Cord Stimulator (SCS) for treating chronic low back and leg pain in people without prior back surgery (non-surgical back pain). SCS therapy uses an implanted device that delivers mild electrical impulses to interrupt pain signaling that travel the spinal cord, according to the company.

Boston Scientific says the expanded indication is based on data from the SOLIS (SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery) randomized control trial, which met its primary endpoint of reducing pain by 50% at its three-month interval. It says the device also demonstrated “significant and sustained pain relief. Followed out to one year, 84% of patients treated with the WaveWriter Systems reported significant pain relief of greater than 50% and sustained improvement in their ability to participate in activities of daily living, with a mean 25-point improvement in disability as measured by the Oswestry Disability Index.”

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