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Motion Is Back In Spine Market

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.

While the spine market has been in the doldrums since late 2010 when 20% of spine procedures were wiped out by payor pushback, there may be a lot more going on in this $7 billion global market than initially meets the eye. (See Also see "Spine Market Dx: Increasing Pain and Instability" - Medtech Insight, 1 December, 2010. and Also see "Beyond INFUSE: Spine Community Searches For Answers, Alternatives" - Medtech Insight, 1 September, 2011..) In less than a month, the US Food and Drug Administration (FDA) has approved three spine Premarket Approval (PMA) applications – for Globus Medical Inc.’s SECURE-C and NuVasive Inc.’s PCM (both cervical disc replacements [CDRs]) and for Paradigm Spine LLC’s coflex Interlaminar Stabilization Device, a nonfusion device for treating lumbar stenosis. The last time a spine product received PMA approval was in 2009.

Additionally, there are two more cervical discs, LDR Spine Inc.’s Mobi-C and SpinalMotion Inc.’s Kineflex C, in the near-term...

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