Zimmer’s TM Ardis Interbody System, a new porous metal interbody implant for the lumbar spine, is being released commercially across Europe after its introduction at the 2012 SpineWeek meeting in Amsterdam earlier this month. At the same time the company has announced its launch in the United States.
The TM Ardis Interbody System utilises Zimmer’s proprietary Trabecular Metal Technology, a highly-porous material that resembles the structure, function, and physiology of trabecular bone. Trabecular Metal Material supports bone in-growth between the implant and the bone, enabling biologic fixation.
Zimmer designed the TM Ardis implant with a large surface area available for biologic fixation, which means the Trabecular Metal Material of the implant can more evenly distribute the load and decrease the risk of stress shielding. The TM Ardis implant also features an updated, anatomical shape that the company claims allows it to be inserted into the disc space more easily. The TM Ardis Interbody System has one of the most extensive size offerings on the market to allow the implant to more closely match a variety of patient anatomies.
“Products like the TM Ardis System with Trabecular Metal Technology align with Zimmer’s strategy to develop innovative technologies that are designed to restore patient mobility, alleviate pain and improve the quality of life for patients around the world,” said Steve Healy, President, Zimmer Spine. “Our objective is to create personalized therapies, procedures and implants to improve patient outcomes while lowering healthcare costs.”
The TM Ardis Interbody System is indicated for use as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had 6 months of non-operative treatment.
The TM Ardis Interbody System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
Source: Zimmer Holdings, PR Newswire