The CURE ACP allows surgeons to utilize the cervical plating system along with its novel cervical interbody fusion device, cleared in 2015, which is manufactured with the PEEK-OPTIMA™ HA Enhanced polymer offered by Invibio Biomaterial Solutions.
Atlanta, GA (PRWEB) October 21, 2016
In July of this year, Meditech Spine received its US Federal Drug Administration (FDA) 510(k) clearance to market the next generation of cervical plates to complement its Talos®-C (HA) line of interbody devices. The CURE Anterior Cervical Plate (ACP) allows surgeons to utilize the cervical plating system along with its novel cervical interbody fusion device, cleared in 2015, which is manufactured with the PEEK-OPTIMA™ HA Enhanced polymer offered by Invibio Biomaterial Solutions. PEEK-OPTIMA HA Enhanced is a novel material for interbody fusion devices. Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, is fully integrated, not coated, into the PEEK-OPTIMA matrix, making it available on all surfaces of a finished device.
When a cervical disc wears out and loses height it can compress on nerves, causing neck pain, arm pain, and numbness or tingling in the arms and hands. These are common symptoms of Degenerative Disc Disease (DDD). A cervical decompression and fusion may help relieve the symptoms of DDD in the neck. It is estimated that over 300,000 cervical fusions are performed each year in the United States. The CURE ACP is the newest product offered by Meditech Spine to treat patients who need an anterior cervical fusion.
The CURE ACP is a titanium plate that incorporates a unique, patent pending, one-step locking mechanism to prevent screws anchored on the spine from loosening and backing out. It is also designed with a large graft window and streamlined instruments to make it easier on hospital and surgery centers to process the system.
The CURE ACP System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The cages are intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1.
Meditech’s philosophy of giving back led to a partnership with CURE International, the namesake of the CURE ACP, an organization that serves children with physical disabilities in underserved areas of the world. A portion of proceeds from the sale of every plate will help CURE International treat patients in underserved areas who are in need of surgical care.
Brad Prybis, M.D., a board-certified spine surgeon, and co-developer of the CURE ACP System, performed the first procedure with the CURE ACP in Carrolton, GA. With over 3,000 attendees, Dr. Prybis will be presenting his experience using the Talos®-C (HA) Cervical IBF device at the annual North American Spine Society (NASS), meeting in Boston, MA. Presentations will take place from 10:00 to 10:30 am and 3:05 to 3:30pm on Wednesday, October 26th, in Invibio’s booth #831. Invibio demonstrated its PEEK-OPTIMA HA Enhanced polymer performance in pre-clinical studies, with greater new bone formation and higher quality of new bone bridging compared with PEEK-OPTIMA Natural at early time points.1 A previous study that evaluated the bone on-growth of the two implantable polymers in a bone defect model in sheep, revealed that PEEK-OPTIMA HA Enhanced resulted in approximately 75% direct bone apposition as early as four weeks following implantation.2
1. Study evaluated the in vivo response to PEEK-OPTIMA Natural, PEEK-OPTIMA HA Enhanced and allograft in a cervical spine fusion model in sheep. Data on file at Invibio. This has not been correlated with Human clinical experience. Study did not use Meditech Spine products.
2. Study evaluated the in vivo response to PEEK-OPTIMA Natural and PEEK-OPTIMA HA Enhanced in a large animal model. Data on file at Invibio. This has not been correlated with human clinical experience. Study did not use Meditech Spine products.