Alphatec Spine Rolls Out Four New Products at NASS

During the recent annual meeting of the North American Spine Society (NASS), Alphatec Holdings,Inc., the parent company of Alphatec Spine, Inc., a manufacturer of surgical products for spine disorders, received CE Mark from the European Union for its HeliFix inter-spinous spacer system and Solus ALIF System. This will allow the company to sell the devices in Europe.

The HeliFix is a minimally invasive, non-fusion solution for lumbar spinal stenosis, a degenerative condition that affects the aging population worldwide.

The company estimates that nearly 600 million people aged 60 years or older are diagnosed with LSS. The 2009 market size in Europe for inter-spinous devices was approximately $50 million with estimated growth of 12 percent, company officials said.

The HeliFix implant acts as an extension blocker at the affected vertebral levels and relieves symptoms associated with LSS. The device currently isn’t available for sale in the United States.

The Solus ALIF System is a zero-profile, single-action locking implant that is used in anterior lumbar inter-body fusion 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, according to the company. The system currently is under FDA review for 510(k) clearance.

Alphatec Spine also featured two new product releases in the U.S. market, the Aspida anterior lumbar plating system and the PureGen osteoprogenitor cell allograft. The Aspida system recently received 510(k) clearance and features a slim profile, a single-action self-locking mechanism and a dual-lead threaded screw, all of which are designed to minimize the disruption of tissue near the implant and reduce operating time for the surgeon.

The company also released PureGen, a highly concentrated, pure population of adult stem cells that originates in bone marrow and is collected from live, healthy donors for optimal cell functionality. Unlike stem cell products that are currently commercially available, which have an unknown population of mesenchymal stem cells (MSCs) and are harvested from cadaveric donor tissue, PureGen delivers a similar potency of pure adult MSCs without the need for cultural expansion, officials explained. PureGen is the first pure adult stem cell to be released in the spinal market, according to the company.