Archus Orthopedics (Redmond, Washington) said it has received CE mark approval of its Total Facet Arthroplasty System (TFAS). The spinal implant is 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, often accompanied by spine fusion. The TFAS replaces the degenerative facet joints with a prosthetic joint implant that restores stability and normal motion to the spine, eliminating the need for fusion. Chairman and CEO Jim Fitzsimmons said that the company would not pursue a full-scale launch of the TFAS 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 said it has filed with the FDA for an investigational device exemption for the TFAS and plans to initiate a pivotal clinical trial in the U.S. later this year.

Atrium Medical (Hudson, New Hampshire) said it has received CE mark approval for the HyperLite LX Rapid Exchange PTCA Catheter. The catheter is available in diameters ranging from 1.5 mm to 4.0 mm. Atrium's HyperLite LX series includes new features such as a coaxial reinforced push transfer segment for improved handling and tracking efficiency. The HyperLite LX combines next-generation balloon welding technology with a more advanced QUAD-Fold balloon to offer one of the lowest crossing profiles available at .026". The catheter allows for 5 Fr guide catheter compatibility, and dual-catheter kissing balloon techniques with a 6 Fr guide catheter, with a tip entry profile of .017".