Devices

Abbott Spinal Stimulation Devices OK for Back Pain

FDA has approved an expanded indication for Abbott spinal cord stimulation (SCS) devices — treating chronic back pain in those who have not had or are not eligible to receive back surgery. Previously, the devices were approved for treating intractable pain of the trunk and limbs. The expanded use was approved based on data from the company’s DISTINCT study, which “demonstrated that Abbott’s proprietary BurstDR SCS technology improved pain levels, ability to perform daily activities and emotional well-being in people with chronic back pain,” the company says.

The 270-patient study evaluated participants who suffered for an average of 12.8 years with pain. “Results at six months for the first 200 patients demonstrated clear clinical evidence supporting BurstDR stimulation therapy as an effective treatment for chronic back pain and were sustained at the 12-month follow-up,” the company says, adding that 91.4% of people who received SCS therapy obtained significant pain relief or significantly improved function.

The expanded indication applies to all of Abbott’s SCS devices, including the recharge-free Proclaim SCS and the rechargeable Eterna SCS platform. All of Abbott's SCS devices feature the low-energy BurstDR waveform, which the company says uses pulses of mild electrical energy to change pain signals as they travel from the spinal cord to the brain.

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