Tampa (February 24, 2010) - Tampa General Hospital announced today the first use of XL TDR® lumbar disc replacement device in Florida, using a minimally invasive lateral (side) approach to the spine. This procedure is part of a prospective, controlled, multi-center clinical trial to evaluate the safety and efficacy of XL TDR by comparing the outcomes of patients to traditional spinal fusion surgery.
The first patient, a 43 year old female, was treated at Tampa General by Dr. Juan Uribe, neurosurgeon with USF Health and Tampa General, on Mon, February 22, 2010.
Dr. Uribe said, “The minimally invasive extreme lateral total disc replacement is a great alternative for the management of select patients with degenerative disc disease.”
The procedure is performed through the patient’s side. The lateral approach provides the least amount of tissue disruption (muscles, ligaments, blood vessels, and abdominal organs) compared to traditional posterior (back) or anterior (front) approaches. The procedure is extremely straightforward and will be familiar to any surgeon who has experience performing the XLIF (eXtreme Lateral Interbody Fusion) procedure.
The clinical trial to evaluate XL TDR will include over 200 patients across an estimated 15 clinical investigation sites. The full enrollment timeframe is estimated to be between 12 and 18 months.
About XL TDR
XL TDR is a metallic prosthetic joint or total disc replacement that replaces a degenerative intervertebral disc. Like fusion, total disc replacement supplants 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 of the spine. Once implanted between the vertebrae, XL TDR is designed to restore height and to replicate the motion characteristics of an intact healthy disc.