MILFORD, Conn., Sept. 25 /PRNewswire/ -- Impliant, Inc. (www.impliant.com), a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that it has enrolled its first patient in a pivotal IDE trial of its TOPS(TM) System, a Total Posterior Arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis.
(Photo: http://www.newscom.com/cgi-bin/prnh/20060925/NYM214 )
The procedure was performed by Paul McAfee, M.D., Chief of Spine Surgery, St. Joseph's Medical Center. Dr. McAfee stated, "What I like about the TOPS(TM) device is that it allows for a wide decompression that is often necessary for severely stenotic patients. The TOPS(TM) System then stabilizes the segment while allowing motion by effectively replacing all of the posterior structures removed during the decompression. I was very satisfied with the simplicity and ease of the procedure. I anticipate that we will be able to recreate the outstanding results we have seen outside the United States with the TOPS(TM) device."
"We are pleased to be starting our pivotal study ahead of schedule," said Barry Sands, Vice President, Regulatory, Clinical and Quality Affairs of Impliant. "The fact that we are enrolling patients within five weeks of FDA approval indicates the level of enthusiasm among our investigators."
Impliant is enrolling patients in a prospective, randomized study comparing the TOPS(TM) System to a traditional posterior fusion. "We are excited to start the study and prove that the TOPS(TM) System is a safe and effective motion alternative for patients suffering from moderate to severe stenosis," said Todd Potokar, President of Impliant. "Due to the prevalence of the disease, we believe a large number of patients stand to benefit from the technology."
Impliant is applying cutting-edge materials and biomechanical engineering techniques to develop a new class of spine arthroplasty devices that target over 500,000 patients worldwide who undergo fusion surgery and could benefit from a Total Posterior Arthroplasty solution.
About the TOPS(TM) System
Impliant's TOPS(TM) System, a mobile posterior device, is designed to stabilize but not fuse the affected vertebral level to alleviate pain stemming from spinal stenosis with or without degenerative facet arthrosis, and spondylolisthesis. Following a laminectomy and medial facetectomy, the device is affixed to the spine via four pedicle screws using a standard posterior surgical approach. Impliant believes that the TOPS(TM) System could benefit patients worldwide undergoing spinal fusion surgery each year. The TOPS(TM) System is not approved for sale in the United States.
About Impliant, Inc.
Impliant, Inc. is a privately held company engaged in the development of novel spine arthroplasty solutions for motion preservation. The company is currently developing the TOPS(TM) System, which is designed to alleviate pain resulting from degenerative facet arthrosis, spondylolisthesis, and spinal stenosis by stabilizing but not fusing the affected vertebral level. Impliant is headquartered in Milford, CT with research facilities located in Ramat Poleg, Israel. For more information about Impliant, please visit www.impliant.com.
Ron Sacher, CEO
Todd Potokar, President
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