Archus Orthopedics, Inc. today announced the first human use of its facet replacement technology to complement an artificial disc. The landmark case was performed by Dr. Karin Büttner-Janz, Dr. Hansen Yuan and Dr. Friedrich Kleinod at the Vivantes Clinic in Berlin, Germany, and involved a patient who previously underwent disc replacement surgery and later developed symptomatic facet joint degeneration. “Generally in this situation the patient is converted to spine fusion,” said Dr. Karin Büttner-Janz. “With the Archus facet replacement system, we are now able to allow these patients to keep their artificial disc, retain motion, and avoid fusion,” she added.
Artificial discs are implanted in patients whose natural disc has degenerated over time, resulting in chronic back pain. Historically, these patients have been treated by spine fusion surgery. Disc replacement surgery has demonstrated equivalent clinical benefit and has the added advantage of restoring normal motion to the spine. Currently, two artificial discs are approved by the Food and Drug Administration for sale in the United States, and a third disc is nearing approval. Industry analysts project rapid adoption of artificial discs once broader reimbursement is obtained.
While artificial discs represent an attractive alternative to spine fusion, they are not applicable to all patients. Many potential disc recipients are contraindicated because they also exhibit evidence of facet joint degeneration. These patients are, instead, treated by conventional spine fusion because it addresses both the disc and facet issues. In addition, since spine degeneration is often a progressive disease, some artificial disc recipients return later with degenerative facet joint problems that require revision to spine fusion. “In both scenarios, the primary issue is facet joint degeneration resulting in the need to fuse the patient, either immediately or later,” said Dr. Hansen Yuan, who spearheaded development of the company’s unique product family to compliment artificial discs. “Replacing the degenerative facet joint and maintaining spine motion is a much better solution than fusion,” he added.
“Combining disc or nucleus replacement therapy with facet replacement expands the market for these technologies and gives surgeons all the tools they need to rebuild the entire spinal segment,” said Jim Fitzsimmons, chairman and chief executive officer. “This total joint replacement approach is consistent with where things have gone in orthopedics and where they are ultimately going in spine,” he added. Archus indicated that its entire family of facet replacement products has already received CE Mark approval in the European Union, where marketing trials are ongoing.