11172017Headline:

Philadelphia, Pennsylvania

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Jamie Sheller
Jamie Sheller
Attorney • (800) 883-2299

Panel Recommends Approval For Spinal Replacement Disks

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Medtronic received good news when an FDA panel voted to recommend approval for artificial upper spine disks. The stainless steel device is meant to replace degenerating disks in the back. The panel found that in clinical trials, the replacement disks performed at least as well as spinal fusion surgery. However, the panel approval carries several conditions, including more safety studies by Medtronic. If the FDA gives its approval, Medtronic could become an early frontrunner in a potentially $1 billion market. Other companies, such as Johnson & Johnson, Synthes and Stryker, are also developing upper spine replacement disks. Critics of replacement disks say that they are an unproven technology, with insufficient data on long-term use.