Devices

Empirical Spine PMA for Spinal Tension Band

Empirical Spine says it will submit a rolling PMA for its LimiFlex Paraspinous Tension Band for treating patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The submission will be based on data from a pivotal trial comparing outcomes from patients who receive either LimiFlex or transforaminal lumbar interbody fusion after decompression surgery. The company says the agency has accepted the “PMA shell” and the plan is to submit all three PMA modules by the end of the year.

The LimiFlex IDE trial’s endpoint, Empirical says, is the rate of overall clinical success at 24 months. Currently, over 200 patients have reached 12 months follow-up and more than 100 patients have achieved the 24-month primary endpoint. “The goal is to show that patients can achieve fusion-equivalent results without the fusion,” it says.

The device is designed to stabilize the spine without fusing it and thereby preserving motion. It is placed following a standard decompression surgery, typically in less than 20 minutes, the company says, adding that it could be inserted in an outpatient or ambulatory surgery procedure.

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