Globus Posterior Disc Replacement

[Tim]

Hi
I came across this article listed by Harrison on the ADR Support site and thought readers here might find it of interest:

Globus Medical Announces First Posterior Disc Replacement

Company Achieves Historical Milestone in the Treatment of Spine Disease

AUDUBON, Pa., April 10 /PRNewswire/ -- 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.

About Globus Medical, Inc.

Globus Medical, Inc. is the largest privately-held spinal implant manufacturer in the world, with more than $100 million in annualized revenue. Based in Audubon, Pa., the company was founded in 2003 by an experienced team of spine professionals with a shared vision to create
products that enable spine surgeons to employ both fusion and motion preservation solutions to promote healing in patients with spinal
disorders.

Globus Medical has a full portfolio of spinal fusion products, burgeoning initiatives in biomaterials development and minimally invasive approaches, and is among the world leaders in the development of motion
sparing technology. Additional information can be accessed at http://www.globusmedical.com.

All the best
Tim

[mmglobal]

At the last NASS and SAS meetings, we got to see a whole new crop of artificial discs. Most were knock-off of current designs, but there were some very cool innovations. I even got to see some prototypes that world-leading developers were still in the development process with... very cool stuff.

Like with so many other spine surgeries, there are many compromises that must be made. With posterior decompressions, we've talked about open microscopic surgery vs endoscopic surgery. The various techniques trade-off the amount of collateral damage caused by the surgery, the surgeon's ability to visualize the surgical field, the ability to access the surgical field (tool size, angles, etc.. ) There are huge advantages and disadvantages for all of each type of surgery. A surgeon once told me that "an endoscope is a poor surgeon's microscope." I did not understand this until years later when I had seen so many endoscopic and microscopic surgeries. The trade-offs are significant. (Having said this, I do believe that in many cases, the advantages of endoscopic spine surgery outweight the disadvantages... with certain indications... that's what I'd choose for myself.)

As we see the new crop of total disc replacements, we'll come to understand a new set of trade-offs. Over the years, we've seen the features of the current design change as the access techniqies improved. Early on, the plates were smaller to allow easier implantation. As the understanding of the devices developed, access techniques improved, materials manufacturing capabilities improved., the plates became larger. As long as I've been speaking to the surgeons about devices and techniques, they have been clammoring for better shapes and sizes to cater for different shape and sized spaces... extra deep... extra wide.

Now we are going to see plate size and shape dictated by access technique. The designs I've seen for straight lateral and posterior access were necessarily smaller and more slender shapes than current discs. This allows implantation through access techniques that are much more limited that the current techniuqes. I'm lucky enough to be able to spend time touring the exhibit halls with many of the most experienced ADR surgeons in the world and discuss these issues. What is going to keep this device in place? Will it move around? What will keep it from subsiding?

This new device and approach are very exciting. There are a lot of incredible people working on the challenges of alternate approaches for total disc replacement. I believe that the advances we'll see in the years to come will have us laughing at the antique discs we are implanting today. I'm really looking forward to SAS next month in Berlin. I can't wait to hear what Pimenta has to say.

All the best,

Mark

PS, Tim, I hope you don't mind... I moved your post to it's own thread... thanks for sharing this.

[ans]

This is exciting news. I especially like that the ADRs w/be safer to revise - or hopefully so among the other goodies.

I remember Dr. Regan several yrs. ago telling me that he was studying lateral approaches with a Brazilian doc.

Thanks for posting this.