Devices

FDA OKs Vagus Nerve Stimulation for Stroke Patients

FDA has approved a MicroTransponder PMA for the Vivistim Paired VNS System, a rehabilitation device intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation (VNS). “To use the Vivistim System, an implantable pulse generator (IPG) — which generates a mild electrical pulse — is implanted just under the skin in the chest of the patient,” an FDA release says. “Attached to the IPG is a lead wire that is implanted under the skin and leads up to electrodes that are placed on the left side of the neck where the vagus nerve is,” it says.

Approval was based on data from a 108-patient clinical study of 108 patients who were asked to complete 300-400 physical therapy exercises for 90 minutes a day, three times a week for six weeks. “The control group received only a very low level of VNS for the first five exercises of the 300-400-movement series and had no stimulation whatsoever for the rest of each session,” FDA says. “The treatment group received the appropriate amount of VNS throughout all 90-minute rehabilitation sessions.” Progress was measured as an increase in motor function from baseline after six weeks of therapy. Patients in the treatment group had an average score increase of five points, whereas patients in the control group had an average score increase of 2.4 points.

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