Vertiflex’s Superion Interspinous Spacer Gets FDA Panel Date
This article was originally published in The Gray Sheet
FDA’s Orthopaedic and Rehabilitation Devices Panel will meet in December to consider Vertiflex’s submission to support approval of the Superion interspinous spacer to treat moderate lumbar spinal stenosis.
You may also be interested in...
In less than a month, the US Food and Drug Administration (FDA) recently approved three spine PMAs, two for cervical disc replacement devices, and there are two more cervical discs in the queue for near-term PMA approval. All of this activity suggests the $122 million US cervical disc market is about to gear up.
Xeltis, a Netherlands-based company producing cardiovascular implants to stimulate natural regeneration of biological tissue, has received funding from the European Union’s rescue fund.
Manufacturers can’t use the US FDA’s voluntary eSTAR product submission program for de novo requests until January – but they can start practicing now on how to use eSTAR for that review pathway.