Motion Is Back In Spine Market

Article preview from Medtech Insight - December, 2012

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.

 

Motion Is Back In Spine Market

Article preview from Medtech Insight - December, 2012

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. 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 PMA queue. In November, LDR received an approvable letter for the Mobi-C, the first cervical disc for both one- and two-level applications. LDR will complete the final requirements for approval and expects to launch the Mobi-C in the US in 2013. Currently, BioMedGPS is tracking 11 companies and 12 products in its SmartTRAK Spine Module that are either on the market or in various stages of US regulatory review. The $122 million US cervical disc market, hampered by reimbursement issues, is about to gear up.

Unlike the hype surrounding lumbar artificial discs – which fell flat after more than $1 billion was spent on acquisitions and clinical results showed outcomes comparable to fusion, at best, resulting in noncoverage decisions by payors – companies with CDRs have been quietly doing their homework and generating clinical data mostly via investigational device exemption (IDE) studies comparing CDR results with those for anterior cervical discectomy and fusion (ACDF).

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