09.14.15
The U.S. Food and Drug Administration has cleared expanded indications for posterior cervical screw placement for Carlsbad, Calif.-based Spinal Elements Inc.’s Lotus posterior cervical/thoracic spinal system. Previous clearance had allowed for screw placement only in the thoracic (T1-T3) spine. The new clearance now broadens the Lotus system’s indications for the placement of screws in the cervical (C1-C7) spine, providing surgeons with more surgical treatment options for improved treatment of various posterior cervical and thoracic pathologies.
“The use of screws in the posterior cervical spine as an effective treatment option is well documented in the literature. Pursuing this clearance illustrates Spinal Elements’ drive to facilitate the best possible care of my patients,” said John G. Devine, M.D., chief, spine surgery service and professor of orthopedic surgery at Georgia Regents University in Augusta, Ga.
Jason Blain, president of Spinal Elements added, “Achieving these expanded indications for our posterior cervical-thoracic fixation system aligns with our company’s mission to set a new standard. We endeavor to provide our surgeons with the most advanced implants, instruments and techniques available.”
The Lotus Posterior Cervical/Thoracic Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical and thoracic spine; traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The Lotus system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
“The use of screws in the posterior cervical spine as an effective treatment option is well documented in the literature. Pursuing this clearance illustrates Spinal Elements’ drive to facilitate the best possible care of my patients,” said John G. Devine, M.D., chief, spine surgery service and professor of orthopedic surgery at Georgia Regents University in Augusta, Ga.
Jason Blain, president of Spinal Elements added, “Achieving these expanded indications for our posterior cervical-thoracic fixation system aligns with our company’s mission to set a new standard. We endeavor to provide our surgeons with the most advanced implants, instruments and techniques available.”
The Lotus Posterior Cervical/Thoracic Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical and thoracic spine; traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The Lotus system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.