Press Release |
Applied Spine Adds Investigational Site for IDE Trial
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Allegheny General Hospital newest site for Stabilimax® IDE enrollment ROCKY HILL, Conn.--(Business Wire)-- Applied Spine Technologies (www.appliedspine.com) announces the first patient surgery at Allegheny General Hospital in Pittsburgh, Pennsylvania, as part of their FDA approved Investigational Device Exemption (IDE) clinical trial designed to evaluate the safety and effectiveness of the Stabilimax Dynamic Spine Stabilization System. The surgery was performed by Donald M. Whiting, M.D. on October 26th. Allegheny General Hospital is the latest clinical site to participate in the Stabilimax trial. "We are very pleased to welcome Dr. Whiting and the entire spine team at Allegheny General as our newest investigational site," said Craig Corrance, Chief Executive Officer of Applied Spine. "Allegheny General Hospital`s status as a nationally recognized comprehensive spine Center of Excellence reflects our strategy of partnering with leading U.S. spine facilities for the duration of our IDE clinical trial." About Applied Spine Technologies Inc., and Stabilimax 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. recently received permission from the FDA to resume a multi-center, randomized, controlled clinical trial to compare posterior dynamic stabilization using the Stabilimax 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. Applied Spine Technologies Terry Brennan, CFO, 866-594-3116 email@example.com Copyright Business Wire 2009