Archus Orthopedics, Inc. announced this morning that it has formally initiated enrollment in the U.S. clinical trial of its Total Facet Arthroplasty System or TFAS(TM).
The TFAS(TM) is patented spinal implant designed to treat spinal stenosis. The device replaces degenerative facet joints with a prosthetic joint implant intended to restore stability and normal motion to the spine, thereby eliminating the need for fusion.
According to the company, the first U.S. case was successfully performed on August 26th by Dr. Scott Webb from the Florida Spine Institute. Dr. Webb stated in a company press release that "the case went extremely well and I am delighted with the outcome," and that he sees the facet device as "an important new treatment option for my spinal stenosis patients." According to the Company, a total of ten TFAS(TM) cases have been successfully performed to date worldwide, with the longest patient follow-up at four months. Patients have regained mobility without pain, and follow-up radiographic and fluoroscopic images show the TFAS(TM) correctly aligned and functioning properly. Dr. Webb has been implanting the device in Europe. The Company reported in May that all of these cases were successful with no complications, and all patients were reported to be doing well post operatively.
Archus received its Investigational Device Exemption ("IDE") for the TFAS(TM) from the FDA in March which allowed the Company to begin treating patients in the United States.
