France-based FH Orthopedics has a new spine unit which just introduced a cervical disc to go along with its elastic artificial disc for lumbar applications.
The company announcement on November 5, 2014 says the device, the CP-ESP, has received CE Mark and is available in heights from 5mm to 7mm with three different footprints. The lumbar version, the LP-ESP, was according to the company, one of the world’s first monobloc lumbar disc replacements implanted, receiving CE Mark in 2004.
Using a minimally invasive anterior approach, the disc, says the company, offers greater shock absorption and automatic return than traditional disc replacements using ball and socket technology.
Monobloc Design
The monobloc design of the implants feature two titanium alloy end-plates and cap closures separated by a supple polycarbonate urethane cushion (Bionate TPU) and a silicone core filled with compressible beads. The company says the supple cushion acts as a shock absorber while also providing “oxidative stability, undetectable wear debris and mechanical strength.” Ridges on the titanium alloy plates, adds the company announcement, “transform any rotation between the two metallic parts into compression and traction forces in the internal deformable assembly and prevent micro motion.”
Small pegs protrude from the end-plates to provide “primary fixation between the vertebrae, and effective secondary fixation is achieved with an HAP (hydroxyapatite) coating on an undercoat of pure porous textured titanium, T40, achieving good bony fixation over time.”
The company says both implants “provide up to 6 degrees of freedom: flexion, extension, right and left bending, axial rotation, and translation. In addition, they offer an adaptive center of rotation, improved stability, no surface bearing for increased lifetime of the device, automatic return, and shock absorption. They have been tested up to 40 million cycles.”
Not FDA Approved
The implants are not FDA approved and were developed jointly over the past ten years by the Hôpital Pitié Salpêtrière in Paris, the CEA (French Atomic Energy Commission) and the University of Paris VI, in association with OSEO Innovation (ANVAR).
Hook Heads U.S. Operations
Eric Hermann is the new director of the spine unit based in Mulhouse, France. He previously managed the company’s U.S. subsidiary. Replacing Hermann in the company’s Chicago U.S. headquarters is Jim Hook. Hook worked at Small Bone Innovations, Inc. as senior vice president of North American sales. Prior to that, he was general manager of Tornier, Inc.
