REDMOND, Wash., Aug. 16 /PRNewswire/ -- Archus Orthopedics, Inc. today announced that over one hundred patients worldwide have now been successfully implanted with the company's Total Facet Arthroplasty System(R) or "TFAS(R)". The company indicated that the vast majority of TFAS cases have been performed in the United States in an ongoing IDE study approved by the U.S. Food and Drug Administration.
TFAS is a novel 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 moderate to severe 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.
"This is an important milestone for facet arthroplasty and for Archus Orthopedics," said Jim Fitzsimmons, chairman and chief executive officer. "Our study results to date are demonstrating clinically significant improvement in patient symptoms and function. With longest patient follow-up now well over two years, we are confident that this is a durable implant and procedure," he added.
In addition to TFAS, Archus is developing a suite of products to address other important clinical applications for facet joint replacement. "We expect to report first human implants of these devices this year," said Fitzsimmons.
About Archus Orthopedics
Founded in July 2001, Archus Orthopedics is a privately held company developing a family of reconstructive implants to treat a variety of spine disorders resulting from degenerative changes in the facet joints. Archus has received venture capital funding from MPM Capital, InterWest Partners, Polaris Venture Partners and Johnson & Johnson Development Corporation, in cooperation with DePuy Spine.
Archus Orthopedics, Inc.
CONTACT: Jim Fitzsimmons, Chairman and Chief Executive Officer of ArchusOrthopedics, Inc., +1-425-284-3650, firstname.lastname@example.org