Healthcare Industry News:  Spinal Stenosis 

Devices Neurosurgery Orthopaedic

 News Release - December 8, 2009

Applied Spine Announces First Use Outside the U.S. of the Stabilimax(R) Dynamic Spine Stabilization System

ROCKY HILL, Conn.--(HSMN NewsFeed)--Applied Spine Technologies (www.appliedspine.com) announced today the first two Stabilimax surgeries performed outside of the United States. The surgeries were performed in Johannesburg, South Africa, by Ajay Maharaj, MD, at Sunninghill Hospital. The Stabilimax Dynamic Spine System is currently part of an IDE multi-center, randomized, controlled clinical trial in the U.S.

Commenting on the procedure, Dr. Maharaj stated, "Our first Stabilimax implantations went exceedingly well. We are pleased to be the first facility outside of the United States to take part in utilizing this exciting new technology. Stabilimax offers an intriguing alternative to spinal fusion; the opportunity to stabilize the spine without eliminating motion for patients with Spinal Stenosis or herniated nucleus pulposus, in particular, is an area of great interest to me.”

Craig Corrance, Chief Executive Officer of Applied Spine adds, “We are very pleased to be partnering with Dr. Maharaj, as well as his colleagues Dr. Louis Nel and Dr Jack Eksteen, in broadening the company’s experience with our Stabilimax System. South Africa offers Applied Spine the opportunity to collect valuable clinical data; but we are also most excited with the chance to commercialize Stabilimax in South Africa, utilizing our CE Mark, for the growing number of surgeons interested in providing their patients with pedicle screw based motion preservation.”

About Applied Spine Technologies Inc., and Stabilimax(R)

Applied Spine Technologies Inc., headquartered in Rocky Hill, Connecticut, is developing the Stabilimax Dynamic Spine Stabilization System, a posterior dynamic stabilization device designed to support an injured or degenerated spine without eliminating motion. Stabilimax is expected to offer numerous advantages over current spinal fixation products and even new artificial disc products—including a much less invasive and less traumatic implant procedure, maintenance of spine motion and disc function, and the potential to prevent or slow adjacent-segment disc disease.

About the IDE Clinical Trial

Applied Spine Technologies, Inc. is currently conducting a multi-center, randomized, controlled clinical trial in the U.S. to compare posterior dynamic stabilization using the Stabilimax(R) Dynamic Spine Stabilization System to traditional spinal fusion stabilization to treat degenerative lumbar Spinal Stenosis. AST has enrolled more than 100 patients to date.

Stabilimax is an investigational device in the United States. It is limited by United States (U.S.) Federal Law for investigational use only.


Source: Applied Spine Technologies

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