Archus Orthopedics, Inc (REDMOND, Washington), a privately-held company developing reconstructive implants to treat a variety of spine disorders resulting from degenerative changes in the facet joints, announced that it has successfully completed in Europe the first human implants of its new TFAS-LSâ„¢ system, representing the first ever facet joint replacement procedures performed at the lumbosacral spinal (LS) level.

The TFAS (Total Facet Arthroplasty System®)-LS complements the company's first product candidate in the US, which has been successfully implanted in >100 patients worldwide, the vast majority treated in the US in an ongoing IDE (Investigational Device Exemption) study approved by the US FDA. The TFAS multicenter, prospective, randomized, controlled, clinical trial is comparing the safety and effectiveness of the TFAS device with posterior instrumented spinal fusion surgery in the treatment of moderate-to-severe degenerative lumbar spinal stenosis. Archus is currently recruiting additional clinical investigators for the TFAS US IDE clinical trial.

Designed to replace the traditional treatment for spinal stenosis (involving decompressive laminectomy surgery often accompanied by spinal fusion), the TFAS and TFAS-LS products replace degenerative facet joints with a prosthetic joint implant intended to restore stability and normal motion to the spine, eliminating the need for fusion. Implanted via an open posterior surgical approach, TFAS is fixed within the pedicles and provides immediate alignment and stabilization of the spinal segment at a single spinal level, L3-L4 or L4-L5, while maintaining anatomical ranges of motion. The TFAS-LS is specifically designed to conform to the unique anatomy of the LS level.

Although Archus must conduct clinical trials of the TFAS-LS and other new products to gain marketing approval in the US, the company's entire device family has already received CE Mark approval for marketing in the EU where it will pursue a broad but controlled product launch in 2008.

Archus raised $35 million last year in a series C financing, with the principal investors being Johnson & Johnson Development Corp and DePuy Spine, Inc, an operating company of DePuy, Inc, a Johnson & Johnson company; previous investors included MPM Capital, InterWest Partners, and Polaris Venture Partners.  

—A. Techman