CARLSBAD, Calif., Oct. 5, 2010 (GLOBE NEWSWIRE) -- Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, today announced that the Company has received CE Mark approval for commercial sale in the European Union and other jurisdictions for its HeliFix Interspinous Spacer System and Solus ALIF System. The receipt of the CE Mark allows Alphatec Spine to begin selling HeliFix and Solus implants in the European Union and certain other jurisdictions that recognize the CE Mark for commercial approval.
The HeliFix Interspinous Spacer System is a minimally invasive non-fusion solution for lumbar spinal stenosis (LSS). Lumbar Spinal Stenosis is a degenerative condition that affects the aging population worldwide. It is estimated that nearly 600 million people aged 60 years or older are diagnosed with LSS. The 2009 market size in Europe for interspinous devices was approximately $50 million with estimated growth of 12%. The HeliFix implant acts as an extension blocker at the affected vertebral levels and relieves symptoms associated with LSS. The HeliFix System is an innovative concept that features an implant with a self-distracting helical tip. HeliFix is not available for sale in the U.S.
The Solus ALIF System is a zero-profile, single-action locking implant that is used in anterior lumbar interbody fusion (ALIF) procedures. Unlike other products that are currently on the market, which require screws or complicated locking mechanisms, the Solus implant can be secured into position in a single step. This single-step mechanism is a significant improvement over similar devices. The 2009 market size for anterior degenerative thoracolumbar fixation in Europe was approximately $45 million. The Solus ALIF System is under FDA review for 510(k) clearance and is currently not available for sale in the U.S.