Devices

Simplify Medical Artificial Disc Approved

FDA has approved a Simplify Medical PMA for its Simplify Artificial Disc for one-level disc replacement indications. The device’s approval is based on clinical data demonstrating that the device “achieved superiority to the fusion control on the composite primary endpoint,” the company says. The prospective trial enrolled 166 Simplify Disc patients at 16 clinical sites across the U.S., and results were compared with a historical fusion control. During the trial, the device was used for one-level cervical implantation between the C3 to C7 vertebrae.

Simplify Disc is a “motion-preserving” cervical artificial disc designed to allow for advanced imaging capability (MRIs), according to the company. It is made of primarily non-metal materials (PEEK-on-ceramic) to allow full diagnostic imaging capability. “The three-piece disc, with a semi-constrained mobile core, is designed to mimic/replicate the natural biomechanical motion of a healthy disc,” it says, adding that implantation involves a three-step procedure.

The company says the disc is currently being evaluated in a separate IDE study in the U.S. for two-level indications. The enrollment for the trial was completed 11/2018.

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