PRINCETON, N.J., July 17 Impliant, Inc., a developer ofnovel spine arthroplasty alternatives to fusion surgery, today announced thatit conducted the first surgery in the United States using a less-invasiveversion of its TOPS(TM) System, a Total Posterior Arthroplasty device designedto treat spinal stenosis with or without facet arthrosis andspondylolisthesis. 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 configurationthat the company feels will further reduce tissue retraction and operativetime during TOPS(TM) implantation.
"The procedure went very well," commented Dr. Coric. "I feel this newversion is a significant improvement over the original TOPS(TM) design and isa natural progression of making implants as minimally-invasive as possiblewhile still being able to withstand the biomechanical demands of the lumbarspine."
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 ofproducts. This line extension is a result of input we received from ourTOPS(TM) investigators to help further improve the ease of insertion of thedevice."
Impliant recently received FDA approval to begin re-enrolling patients inits prospective, randomized IDE study comparing the TOPS(TM) System to atraditional posterior fusion. The company voluntarily suspended enrollment inthe study in September of last year following one device-related failure.
Impliant is applying cutting-edge materials and crossbar biomechanicaltechniques to develop a new class of spine arthroplasty devices that targetover 40% of the patients worldwide who undergo fusion surgery and couldbenefit from a Total Posterior Arthroplasty solution.
About the TOPS(TM) System
Impliant's TOPS(TM) System, a mobile posterior device, is designed tostabilize but not fuse the L3-4 or L4-5 vertebral level to alleviate painstemming from spinal stenosis with or without degenerative facet arthrosis andspondylolisthesis. Following a laminectomy and medial facetectomy, the deviceis affixed to the spine via four pedicle screws using a standard posteriorsurgical approach. Impliant believes that the TOPS(TM) System could benefitover 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 ofnovel spine arthroplasty solutions for some of the most prevalent pathologiesof the spine. The company is currently developing the TOPS(TM) System, whichhas the longest clinical history in the Total Posterior Arthroplasty marketsegment, dating back to January 2005. Impliant is also developing severalnext-generation and multi-level technologies to further increase itsaddressable market. Impliant is headquartered in Princeton, NJ with researchfacilities located in Ramat Poleg, Israel. Shareholders include ElronElectronic Industries Ltd. (Nasdaq & TASE: ELRN). For more information aboutImpliant, please visit http://www.impliant.com.
SOURCE Impliant, Inc.