	Steven E. Chamberlain, MD
	David L. Galt, MD
	Charles N. Versteeg, MD
	Darrell Weinman, MD
	Mark D. Peterson, MD
	Paul Sternenberg, MD
	Yaser A. Metwally, MD
	Heidi T. Bloom, MD
	Omar Abdul-Hadi, MD
	Andy J. Kranenburg, MD
	Richard Owens, Jr., MD

EXtreme Lateral Total Disc Replacement

A Study Investigating Minimally Disruptive Motion Preservation for the Lumbar Spine.

Unlike other total disc replacement devices, XL TDR® is a total disc replacement that is implanted from the patient's side, an approach which radically improves the patient experience. In conjunction with SOLAS,™ the Society of Lateral Access Surgery, NuVasive® is pleased to be sponsoring a clinical study designed to demonstrate the safety and efficacy of XL TDR.

XL TDR seeks to relieve the painful symptoms associated with lumbar degenerative disc disease. However, instead of achieving pain relief through fusion (immobilization of the spinal segment), XL TDR seeks to relieve pain while restoring height and maintaining motion at the spinal segment. Through thoughtful and careful scientific study, we seek to demonstrate the safety and efficacy of this device, compared to other fusion procedures.

What Is Lateral Access?
Lateral access is a minimally disruptive approach to the spine from the side of the body. With sophisticated nerve avoidance technology, the surgeon approaches the spine through a small incision or two on the patient's side, avoiding the abdominal incision of traditional anterior approaches, and the dissection or retraction of the sensitive back muscles, typical of traditional posterior approaches. The lateral approach minimizes or avoids the risk of potential complications such as vascular injury, major bleeding, intestinal injury, ureteral injury, sexual dysfunction, and postoperative back muscle pain.

XL TDR is building on the success of XLIF®, the lateral approach spine fusion procedure introduced by NuVasive in 2003 that has been successful in treating thousands of patients suffering from a variety of spinal disorders.

Conditions & Treatments

What Is Degenerative Disc Disease?
As humans age, one or more of the shock-absorbing, flexible discs between the vertebrae in the lower back begin to deteriorate. Small cracks or tears may form that can lead to disc bulge or rupture. The discs may also lose fluid, resulting in a smaller space between vertebrae. These conditions are referred to as degenerative disc disease (DDD) and may cause an individual pain, numbness, or difficulty walking, reaching, bending over, or twisting.

Current Treatments
Many people who suffer from this condition rely on medications, chiropractic care, and/or physical therapy to relieve the pain. But sometimes, these treatments aren't enough. Cervical disc degeneration is often treated surgically with spinal fusion. In this procedure, the degenerated disc is removed. Because this "cushion" is no longer present, the affected vertebrae are literally "fused" together so that motion can no longer occur.
Most of us with this condition will find relief through medication, chiropractic care, and/or physical therapy without requiring surgical care. However, in some instances, non-surgical care alone is inadequate due to the possibility of the condition’s severity, resulting in permanent impairment. In other instances, non-surgical care alone may not relieve the painful symptoms of degenerative disc disease.

When non-surgical treatment either ceases to provide relief for the patient or is not indicated, surgery may be considered. The current surgical option for lumbar degenerative disc disease is spinal fusion. In this procedure, the degenerative disc is removed and typically replaced with a device which restores the height lost by the degenerative disc. The XL TDR® device facilitates a fusion of the two vertebrae, eliminating the motion between them. The elimination of the diseased disc and the restoration of height provide us with the pain relief we are seeking.

XL TDR Is an Investigational Device That May Be Right for You.
NuVasive® has developed a minimally disruptive surgical device called XL TDR for the treatment of DDD. Participants are now being enrolled in a clinical research study for this total disc replacement device. The study is intended to evaluate the device's safety and effectiveness.

What Is XL TDR?
XL TDR is a metallic prosthetic joint, or total disc replacement, that replaces a degenerative intervertebral disc. Like fusion, total disc replacement is designed to supplant the primary function of the disc – to maintain vertebral spacing to protect the nerves and spinal cord. Unlike fusion, though, total disc replacement seeks to maintain the secondary functions of the disc – providing motion in the spine. Once implanted between the vertebrae, XL TDR is designed to relieve pain, restore height, and replicate the motion characteristics of an intact healthy disc.

For more information, visit www.xlmotion.com or contact our Clinical Research Coordinator at 541-608-2574 or 800-866-9887.

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