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FDA clears spinal facet devices for study, marketing
Under an IDE, researchers will investigate a device for treating spinal stenosis. Another device recently received FDA approval for bilateral facet fixation.
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The Food and Drug Administration has granted a conditional investigational device exemption to Archus Orthopedics Inc. for its Total Facet Arthroplasty System, the company announced.
The Total Facet Arthroplasty System (TFAS) is a spinal implant designed to treat spinal stenosis as an alternative to traditional decompressive laminectomy. The prosthesis replaces the degenerative facet joints and aims to restore stability and normal motion to the spine while avoiding spinal fusion, according to a press release.
The investigational device exemption (IDE) allows Archus to initiate clinical studies of the device to collect data on safety and effectiveness. The FDA requires such data to support a premarket approval application or a premarket notification [510(k)] submission.
The TFAS system already received the CE Mark of approval in the European Union, but this is the first IDE for a facet replacement device in the United States, Jim Fitzsimmons, chairman and chief executive officer of Archus, said in the release.
Archus plans to initiate a prospective, randomized trial comparing the TFAS to spinal fusion performed using posterior pedicle screws over two years follow-up. The IDE allows the company to enroll patients at up to 20 sites throughout the United States, which it expects to begin within the next three months.
“We have had widespread interest from high-profile centers of excellence to participate in the study,” Fitzsimmons said.
Triage Medical Inc. also announced in early March that the FDA granted marketing clearance for its 4.5 mm Bone-Lok spinal fixation device.
The Bone-Lok system is a transfacet pedicle screw for bilateral facet fixation in the treatment of degenerative disc disease, trauma or failed previous fusion. Surgeons can use it with or without bone graft at single or multiple levels in the lumbar spine, ranging from L1 to S1, according to a press release from Triage Medical.
Triage Medical intends to further develop the technology for posterior stabilization in conjunction with anterior lumbar interbody fusions. The company is also currently adapting the technology for cervical spine use, according to the press release.