PRINCETON, N.J., July 17 /PRNewswire/ -- Impliant, Inc., a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that it conducted the first surgery in the United States using a less-invasive version of its TOPS(TM) System, a Total Posterior Arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis. The surgery was performed by Domagoj Coric, MD, Neurosurgeon at the Charlotte Neurosurgery and Spine Associates in Charlotte, NC, as part of the company’s TOPS(TM) Investigational Device Exemption (IDE) clinical study.
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The less-invasive version features a reduced L5 crossbar configuration that the company feels will further reduce tissue retraction and operative time during TOPS(TM) implantation.
“The procedure went very well,” commented Dr. Coric. “I feel this new version is a significant improvement over the original TOPS(TM) design and is a natural progression of making implants as minimally-invasive as possible while still being able to withstand the biomechanical demands of the lumbar spine.”
Andrew Shepherd, Vice President of Sales and Marketing for Impliant, said, “We are pleased to add this less-invasive option to our TOPS(TM) family of products. This line extension is a result of input we received from our TOPS(TM) investigators to help further improve the ease of insertion of the device.”
Impliant recently received FDA approval to begin re-enrolling patients in its prospective, randomized IDE study comparing the TOPS(TM) System to a traditional posterior fusion. The company voluntarily suspended enrollment in the study in September of last year following one device-related failure.
Impliant is applying cutting-edge materials and crossbar biomechanical techniques to develop a new class of spine arthroplasty devices that target over 40% of the 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 L3-4 or L4-5 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 over 500,000 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 some of the most prevalent pathologies of the spine. The company is currently developing the TOPS(TM) System, which has the longest clinical history in the Total Posterior Arthroplasty market segment, dating back to January 2005. Impliant is also developing several next-generation and multi-level technologies to further increase its addressable market. Impliant is headquartered in Princeton, NJ with research facilities located in Ramat Poleg, Israel. Shareholders include Elron Electronic Industries Ltd. . For more information about Impliant, please visit http://www.impliant.com.
CONTACT: Todd Potokar, President & CEO, tpotokar@impliant.com, or Andrew
Shepherd, Vice President, Sales & Marketing, ashepherd@impliant.com, both
of Impliant, Inc., +1-609-779-6800
Web site: http://www.impliant.com/
