Coflex over Decompression in Treating LSS
By MedTech Outlook | Wednesday, January 09, 2019
Paradigm Spine, an innovative leader in spinal implant non-fusion technology, is aimed at delivering surgical, indication-specific, and data-driven products and improving the lives of the patient with spinal diseases through its mission. The company sees the opportunity to improve treatment options for Lumbar Spinal Stenosis (LSS) patients and related spinal deformities and is committed to providing the best-in-class products to improve the quality of life of patients with spinal disease.
Coflex® Interlaminar Stabilization® device is the first and only motion to preserve minimally invasive treatment approved for moderate to severe spinal stenosis following decompression at the affected levels. Coflex® is a single, U-shaped component made of titanium alloy, with a long history of safe use in implantable orthopedic products. This titanium alloy is biocompatible, flexible, and X-ray visible with compressible in extension. The "U" shape is positioned horizontally in clinical use, with its anterior apex and the two long arms of the "U" paralleling the long axis of the spinal processes. The bone-facing surfaces are mounted to offer migration resistance. The company currently delivers several products for spine specialists like coflex-F® and DSS® worldwide. The coflex-F® stabilization system is a rear, non-pedicle additional fixation device intended for use with an interbody cage as a single- level fusion attachment in the lumbar spine (LI- SI).
Paradigm Spine that provides solutions for the treatment of LSS has announced the issuance of a Select Health of South Carolina Clinical Policy for the treatment of LSS in patients who meet certain eligibility criteria, dated 1st September 2018. Decompression is one of the traditional surgical treatment options for treating LSS. In the decompression procedure, bone and soft tissue are removed, and fusion might be required for stabilizing the spine. A non-fusion stabilizing implant Coflex, used for the treatment of LSS, is FDA PMA (Food and Drug Administration Premarket approval) approved. Coflex is used in conjunction with decompression of a spinal fusion. LSS is a debilitating and degenerative disease which is affecting about 1.6 million patients annually. This is often associated with leg and back pain, numbness in legs, and leads to a significant reduction in an active lifestyle.