In a milestone in the treatment of spine disease, Drs. Luiz Pimenta and Paul McAfee performed at the Santa Rita Hospital, in São Paulo, Brazil, what is believed to be the world's first implantation ever of a total disc replacement device using a posterior approach.
"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, state of Maryland.
"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 operation utilized the Globus posterior total disc replacement system
"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."
David Paul, Globus's CEO, announced that his 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.
"The posterior TDR," he stated, "marks the first of several innovative technology advancements in the field of motion preservation that Globus Medical will introduce in 2007."
Globus Medical is the largest privately-held spinal implant manufacturer in the world, with more than US$ 100 million in annualized revenue. Based in Audubon, state of Pennsylvania, the company was founded in 2003.