A Medical Device Daily

Archus Orthopedics (Redmond, Washington) reported successful completion of the first clinical implants of its Total Facet Arthroplasty System (TFAS). The cases were performed in Europe by Dr. Scott Webb, assisted by local surgeons trained by Webb under a fellowship program at the Florida Spine Institute (Clearwater, Florida).

All cases were successful with no complications, and all patients are reported to be doing well post-operatively, the company said.

The new spinal implant is designed to treat spinal stenosis, in which degenerative changes in the facet joints result in compression of spinal nerves producing neurological symptoms in the legs.

Webb, who will serve as an investigator in the company’s Phase I trial, said he was “pleased with the outcomes” of the first TFAS implant. “The instrument set developed by Archus made it very easy to select implant components and achieve precise placement, alignment and assembly,” he noted.

Webb called the TFAs “an exciting alternative to spine fusion.” Traditionally, patients with spinal stenosis undergo decompressive laminectomy surgery, which often is 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 Orthopedics is developing a family of reconstructive implants to treat a variety of spine disorders resulting from degenerative changes in the facet joints.