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First Porous Metal Interbody Implant for Lumbar Spine in the U.S. Introduced

Wed, 06/27/2012 - 5:37am

/PRNewswire/ -- Zimmer Holdings, Inc., a global leader in musculoskeletal health, today introduced the TM Ardis™ Interbody System, the first application of a porous metal implant with an interbody indication for the lumbar spine in the United States. The TM Ardis System extends the applications of Zimmer's proprietary Trabecular Metal ™ Technology, which is currently used across the Company's portfolio, including in the cervical spine.

"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."

Trabecular Metal Technology is exclusive to Zimmer and displays elasticity properties similar to cancellous bone, supporting boney in-growth between the implant and the bone which promotes biologic fixation. Leveraging the unique properties of this exciting material, Zimmer designed the TM Ardis Implant with a large porous surface area available for boney in-growth which supports biologic fixation and more even load distribution which has the potential to decrease the risk of stress shielding.

Trabecular Metal Material is a highly-porous material that is similar to the structure, function and physiology of trabecular bone. No other porous metal material is supported by the amount of peer-reviewed, published clinical data of Trabecular Metal Technology and its history of clinical success in reconstructive orthopaedic applications. This novel material supports boney in-growth, promoting biologic fixation, and has a stiffness similar to cancellous bone.

The TM Ardis Implant features an updated, anatomical shape which allows the implant 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. The TM Ardis Interbody System is available in 40 sizes, with implants available in three lengths, two widths, and eight heights.

The TM Ardis Interbody System is indicated for use with autogenous bone graft 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 six 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.

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