REDMOND, Wash., March 2 /PRNewswire/ -- Archus Orthopedics, Inc. today announced that it has received CE Mark approval of its Total Facet Arthroplasty System(TM) (“TFAS(TM)”). The CE Mark allows the company to freely market the device in any European Union member country.
The TFAS(TM) is a novel, patented 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 spinal stenosis undergo decompressive laminectomy surgery, which is often accompanied by spine fusion. The TFAS(TM) replaces the degenerative facet joints with a prosthetic joint implant that restores stability and normal motion to the spine, eliminating the need for fusion.
Commenting on the approval, Jim Fitzsimmons, chairman and chief executive officer, said, “The CE Mark is a significant milestone for Archus and a clear validation of the rigorous research, design and testing activities completed over the last three years to develop this important new device.”
Fitzsimmons indicated that the company will not pursue a full-scale launch of the TFAS(TM) in Europe at this time. “Initially, our plan is to take a careful, investigational approach with a few prominent centers and accumulate clinical experience with the device,” he said. Archus has filed an Investigational Device Exemption (“IDE”) for the TFAS(TM) and plans to initiate a pivotal clinical trial in the United States later this year.
Treatments for degenerative spine disease represent the fastest growing segment of the orthopedic market. Each year hundreds of thousands of patients undergo a surgical intervention to address their low back condition. Many of these procedures include fusion of one vertebra to another to stabilize the spine or eliminate motion that produces pain. Sometimes ineffective, fusion alters the normal biomechanics of the spine, which can create new problems at adjacent vertebral segments, often requiring re-operation.
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 and Polaris Venture Partners.
Press Contact: Jim Fitzsimmons Chairman and Chief Executive Officer Archus Orthopedics, Inc. 425-869-2100, Ext. 222 jfitzsimmons@archususa.com
Archus Orthopedics, Inc.
CONTACT: Jim Fitzsimmons, Chairman and Chief Executive Officer of ArchusOrthopedics, Inc., +1-425-869-2100, ext. 222, or jfitzsimmons@archususa.com
Web site: http://www.archususa.com/
