Archus Orthopedics Completes Lumbosacral Facet Joint Replacement

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Archus Orthopedics has completed first human implants of TFAS-LS system, representing the first ever facet joint replacement procedures done at the lumbosacral spinal level.Lumbosacral Facet Replacement

Archus Orthopedics has successfully completed the first human implants of its new TFAS-LS system, representing the first ever facet joint replacement procedures done at the lumbosacral spinal level.

The cases were performed in Europe by Dr. Scott Webb from the Florida Spine Institute, assisted by Dr. Radu Prejbeanu and Dr. Ioan Branea.

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The TFAS-LS complements the company's first product, the Total Facet Arthroplasty System(R) or "TFAS(R)", which has been successfully implanted in over one hundred patients worldwide, the vast majority treated in the United States in an ongoing IDE study approved by the U.S. Food and Drug Administration. Both devices are novel spinal implants designed to treat spinal stenosis, a condition in which degenerative changes in the facet joints result in compression of spinal nerves producing neurological symptoms in the legs. Traditionally, patients with moderate to severe spinal stenosis undergo decompressive laminectomy surgery, which is often accompanied by spinal fusion. The TFAS and TFAS-LS replace degenerative facet joints with a prosthetic joint implant intended to restore stability and normal motion to the spine, eliminating the need for fusion. The TFAS-LS is specifically designed to conform to the unique anatomy of the lumbosacral spinal level, which is the junction between the lowest lumbar vertebra and the sacrum.

"These initial cases were very straightforward and I am delighted with the results," said Dr. Scott Webb. "Spinal stenosis is often seen at the lumbosacral level and the TFAS-LS will enable facet joint replacement therapy to be offered to a much broader pool of patients," he added. Dr. Webb, a pioneering spine surgeon, has been a key advisor to Archus for several years. He performed the first TFAS implantation in 2005, which was one of the earliest facet joint replacement procedures ever completed. "There are several important clinical indications for replacing the facet joint, and I am very impressed with the family of devices that Archus has developed to address these conditions," said Dr. Webb.

"This is another significant milestone for Archus Orthopedics," said Jim Fitzsimmons, chairman and chief executive officer. "In addition to expanding our stenosis market opportunity, the TFAS-LS is the first of several new Archus devices utilizing pedicle screw fixation," he added. Fitzsimmons indicated the company's entire second generation product line has now been fully developed and is ready for clinical use. "We will soon be reporting more first implants, including novel devices designed to work in concert with artificial discs," said Fitzsimmons.

While Archus will conduct clinical trials of the TFAS-LS and other new products to gain marketing approval in the United States, the company's entire device family has already received marketing approval in the European Union. "We expect to pursue a broad but controlled launch in Europe next year," said Fitzsimmons.

By Archus Orthopedics, Inc.
This page is updated on May 11, 2013.

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Comments

I have a asymetrical facet l5 s1 I did this squating in the gym for years I am only 30 years old and now halve less tone on my left side in the gleut and the thight my left knee has formed a point on it ,My weight is no longer even on my legs I am very frustrated with this I think on one hand if I had my l5 s1 fused I would lose mobility but at least my weight would be even on my legs u would think. Could I halve the facet replaced.Please someone help me [email protected]
I've been suffering with back pain for about 8 years now, and the last 3-4 have been horrific with digression. I'm only 23 years old and it took several years to find a doctor willing to even look at X-Ray or MRI images for more than about literally 2 seconds before they said they couldn't find anything and sent me on my way (the doctors never even put the images up on the light machine, they just held them up to the ceiling lights for about 2-5 seconds before saying they couldn't find anything or actually call me a liar even though I wasn't seeking pain meds, but just an answer to what is causing pain). I finally found a pair of doctors that were willing to look beyond my age and that people my age shouldn't and can't have these kind of problems, and was told I need the facet joints replaced at 4 levels at L4, L5, T6, and T7 or the joints fused at 3 levels but that the facet joint replacement would be the best option as I would be a patient for life with the fusion. I was told it would be about 3-5 years before the procedure would be approved in the U.S. but after doing some research I'm confused as to whether or not it has been approved and being performed as a non-experimental procedure. I found that they started doing the procedures in 2006 in Europe and have read cases here in the U.S. but have not heard anything "black and white" yes or no regarding if it has been. Does anyone know if the facet joint replacement has been approved in the United States yet by the FDA as a non-experimental procedure? I desperately need something more permenant, I've had numerous non surgical procedures and injections, and have had the periphreal nerves burnt off at 4 levels which has helped, but still suffer severe pain and have not been able to work for 6-7 years and have no source of income due to my condition and really want to be able to work without being in sheer agony or having to rely on pain medication just to be able to make a living.