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Meditech Spine has received the 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. Named in honor of CURE International, the CURE Anterior Cervical Plate (ACP) allows surgeons to utilize a next generation cervical plate along with its novel cervical interbody fusion device, cleared in 2015, and made from Invibio Biomaterial Solutions, PEEK-OPTIMA® HA Enhanced. 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.
“We are humbled to be part of the healing that will take place in the lives of so many because of the CURE ACP System. This innovative product, along with the generous hearts of those who utilize it, will not only help patients here in the United States, it will also help heal many children in underserved countries around the world,” said Rick Klein, CURE Internationals’s Senior Vice President of Development and Sustainability.
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 system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with DDD (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and failed previous fusions.
For Further Information
More on the spinal implant market can be found in the report published by iData entitled U.S. Market for Spinal Implants & Vertebral Compression Fractures.