REDMOND, Wash., March 28 /PRNewswire/ -- Archus Orthopedics, Inc. today announced that the U.S. Food and Drug Administration has conditionally approved an Investigational Device Exemption (“IDE”) for its Total Facet Arthroplasty System(TM) (“TFAS(TM)”), allowing the company to initiate a pivotal clinical trial of the device in the United States.
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 spinal fusion. The TFAS(TM) 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.
The IDE process requires a company to meet a high standard of pre-clinical testing to establish device safety, and successfully pass a rigorous review by the FDA. “This is the first IDE approval of a facet replacement device and clearly establishes Archus as the undisputed leader in this important new space,” said Jim Fitzsimmons, chairman and chief executive officer. “From the very beginning, Archus set its sights on being first to market in the U.S., and this is a very important step along that path,” he added. The company previously announced receipt of CE Mark approval of the TFAS(TM) device, which allows Archus to freely market the device in any European Union member country.
Archus said it will conduct a prospective, randomized trial comparing TFAS(TM) to spinal fusion achieved using posterior, pedicle screw instrumentation. The approval allows the company to enroll patients at up to twenty sites throughout the United States. As is standard in orthopedic and spine device trials, patients will be followed for two years. Fitzsimmons indicated that enrollment in the trial will likely begin within the next two to three months as Archus must receive approval at each participating site before patients can be treated. “We have had widespread interest from high profile centers of excellence to participate in the study,” he said.
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, spinal 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.
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/
