Archus Orthopedics Receives IDE Approval
The FDA has conditionally approved an investigational device exemption for Archus Orthopedics' Total Facet Arthroplasty System (TFAS), allowing the company to initiate a pivotal clinical trial of the device in the U.S.
The TFAS is a patented spinal implant designed to treat spinal stenosis, a condition in which degenerative changes in the facet joints result in compression of spinal nerves producing neurological symptoms in the legs. Traditionally, patients with spinal stenosis undergo decompressive laminectomy surgery, which is often accompanied by spinal fusion. The TFAS replaces the degenerative facet joints with a prosthetic joint implant intended to restore stability and normal motion to the spine, eliminating the need for fusion.
Archus said it will conduct a prospective, randomized trial comparing TFAS to spinal fusion achieved using posterior, pedicle screw instrumentation. The approval allows the company to enroll patients at up to 20 sites throughout the U.S. As is standard in orthopedic and spine device trials, patients will be followed for two years. Enrollment in the trial will likely begin within the next two to three months as Archus must receive approval at each participating site before patients can be treated.