Company Achieves Historical Milestone in the Treatment of Spine Disease
April 10, 2007 – AUDUBON, PA, USA Globus Medical, Inc., the largest privately-held spinal implant manufacturer in the world, announced today what it believes to be the first implantation ever of a total disc replacement device utilizing a posterior approach. The surgery was performed by Drs. Luiz Pimenta and Paul McAfee in Sao Paulo, Brazil.
“I am very excited to be a part of this hallmark event in the treatment of spine disease,” commented Dr. Paul McAfee, MD, Chief of Spinal Surgery at St. Joseph’s Medical Center in Towson, Md. “Utilizing the posterior approach for total disc replacement (TDR) offers several significant advantages compared to the other options for TDRs today: (1) it does not require an access surgeon; (2) it is a much safer procedure in that the iliac veins and inferior vena cava are protected; (3) bail-out and revision procedures are much easier; and (4) the ability to decompress the nerve roots enables a much broader universe of suffering patients to have access to the benefits of TDR technology.”
“The Globus posterior TDR system is designed to restore disc height and return the pattern of motion to the neutral zone without compromising spinal stability or neurological integrity,” according to Dr. Luiz Pimenta, Chief of Spine Surgery at Santa Rita Hospital, Sao Paulo, Brazil. “The procedure did not require a blood transfusion and the patient was able to leave the hospital the day after surgery.”
“The unique design of the Globus posterior TDR enables the two halves to work in unison to achieve the required range of motion,” said Dr. Dilip Sengupta, MD, PhD, Assistant Professor of Orthopedics at the Dartmouth-Hitchcock Medical Center in Lebanon, NH. “Additionally, by preserving most of the annulus and the anterior longitudinal ligament, the device provides for enhanced segmental stability.”
“The posterior TDR marks the first of several innovative technology advancements in the field of motion preservation that Globus Medical will introduce in 2007,” said David Paul, CEO, Globus Medical, Inc. The company intends to seek FDA approval to enter human clinical trials in the US later in 2007, and is in the preliminary planning stages of releasing the device for sale outside of the US as well.