Alphatec Receives FDA Clearance for ALIF Device
Alphatec Holdings, parent company of Alphatec Spine, was granted U.S. Food and Drug Administration 510(k) clearance to market the Alphatec Solus internal fixation anterior lumbar interbody fusion (ALIF) device.
The Alphatec Solus ALIF device features two counter-rotating titanium blades, which are designed to deploy into adjacent vertebrae on a zero-degree axis, locking the device in place. This provides four points of fixation delivered in a single step. The device, which is patented by Alphatec, reportedly provides enhanced segmental stability with a simplified surgical technique, while providing substantial spacing to insert bone graft to help promote rapid fusion at the site.
“We are extremely pleased to announce that the Alphatec Solus ALIF system will soon be available for commercial release within the United States,” said Les Cross, chairman and CEO of Alphatec Spine. “We launched Alphatec Solus in Europe in January this year and thus far it has been a success. Our product development programs will remain a collaborative effort between spine surgeons and our internal development group to ensure that the latest product innovations keep advancing improved patient care in the operating room.”
According to Millennium Research Group, a Canadian research group that gathers data on the medtech industry, the market for internal fixation ALIF spacer devices is estimated to be approximately $129 million in 2013, representing approximately half of the total market for the ALIF spacer devices.
Carlsbad, Calif.-based Alphatec Spine Inc. makes products for the treatment of spinal disorders associated with trauma, congenital deformities, disease and degeneration.