Archus Orthopedics Completes Lumbosacral Facet Joint Replacement
Archus Orthopedics has completed first human implants of TFAS-LS system, representing the first ever facet joint replacement procedures done at the lumbosacral spinal level.Lumbosacral Facet Replacement
Archus Orthopedics has successfully completed the first human implants of its new TFAS-LS system, representing the first ever facet joint replacement procedures done at the lumbosacral spinal level.
The cases were performed in Europe by Dr. Scott Webb from the Florida Spine Institute, assisted by Dr. Radu Prejbeanu and Dr. Ioan Branea.
The TFAS-LS complements the company's first product, the Total Facet Arthroplasty System(R) or "TFAS(R)", which has been successfully implanted in over one hundred patients worldwide, the vast majority treated in the United States in an ongoing IDE study approved by the U.S. Food and Drug Administration. Both devices are novel spinal implants 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 moderate to severe spinal stenosis undergo decompressive laminectomy surgery, which is often accompanied by spinal fusion. The TFAS and TFAS-LS replace degenerative facet joints with a prosthetic joint implant intended to restore stability and normal motion to the spine, eliminating the need for fusion. The TFAS-LS is specifically designed to conform to the unique anatomy of the lumbosacral spinal level, which is the junction between the lowest lumbar vertebra and the sacrum.
"These initial cases were very straightforward and I am delighted with the results," said Dr. Scott Webb. "Spinal stenosis is often seen at the lumbosacral level and the TFAS-LS will enable facet joint replacement therapy to be offered to a much broader pool of patients," he added. Dr. Webb, a pioneering spine surgeon, has been a key advisor to Archus for several years. He performed the first TFAS implantation in 2005, which was one of the earliest facet joint replacement procedures ever completed. "There are several important clinical indications for replacing the facet joint, and I am very impressed with the family of devices that Archus has developed to address these conditions," said Dr. Webb.
"This is another significant milestone for Archus Orthopedics," said Jim Fitzsimmons, chairman and chief executive officer. "In addition to expanding our stenosis market opportunity, the TFAS-LS is the first of several new Archus devices utilizing pedicle screw fixation," he added. Fitzsimmons indicated the company's entire second generation product line has now been fully developed and is ready for clinical use. "We will soon be reporting more first implants, including novel devices designed to work in concert with artificial discs," said Fitzsimmons.
While Archus will conduct clinical trials of the TFAS-LS and other new products to gain marketing approval in the United States, the company's entire device family has already received marketing approval in the European Union. "We expect to pursue a broad but controlled launch in Europe next year," said Fitzsimmons.
By Archus Orthopedics, Inc.
This page is updated on May 11, 2013.