The XL TDR from NuVasive is an investigational intervertebral disc replacement which is implanted using a lateral approach to the lumbar spine. The device has CoCrMo endplates and a ball and socket articulation. As an investigational device, it is not yet available.
The XL TDR is indicated for reconstruction of the disc following discectomy in skeletally mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history radiographic studies.
About Lumbar Artificial Disc
Artificial disc replacement (ADR) is newer type of spinal disc procedure that utilizes an anterior (front – through the abdominal region) approach to replace a painful, arthritic, worn-out intervertebral disc of the lumbar spine with a metal and plastic prosthesis (artificial disc). Artificial disc replacement is primarily considered for patients with isolated 1-level (one disc only) degenerative disc disease. Prior to the development of ADR, spinal fusion was the principal treatment for painful degenerative disc disease that failed to improve with nonoperative management. ADR is generally NOT recommended for patients with spinal fractures, instability, neurologic compression, or multiple level degenerative disc disease – spinal fusion remains the treatment of choice for these conditions. The advantages of ADR include a faster recovery time than spinal fusion and preserved motion at the disc level. The theoretical long-term advantage of ADR, which remains unproven, is the possibility of decreased adjacent level stress and arthritis compared with spinal fusion.
About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.