Devices

FDA Panel Rejects Medtronic PMA for Spinal System

FDA’s Orthopedic and Rehabilitation Devices Panel has voted 7 to 4 not to recommend approval of a Medtronic PMA for the DIAM Spinal Stabilization System for use in skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than one year in duration secondary to lumbar degenerative disc disease at a single symptomatic level from L2‐L5. Panel members said the heterogeneity of the study population impacted the ability of the study data to support the proposed indications for use. It also said that the study observations impacted the ability to interpret the clinical trial results. To address this concern, they recommended that a new clinical study be performed.

The “H”‐shaped polymeric implant, which is implanted through an incision in the posterior lumbar region, is designed to sit between two adjacent spinous processes (L2‐L5) in the lumbar spinal region. It includes polymeric cables that wrap around adjacent spinous processes, and are secured by a titanium crimp. The device’s spacer and cables are designed to stabilize, yet preserve, flexion and extension motion at the treated level, FDA 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