Impliant Restarts European Clinical Activities for Patented TOPS(TM) Spine System
(Logo: http://www.newscom.com/cgi-bin/prnh/20080527/NETU060LOGO )
Impliant had voluntarily suspended all clinical activities in September oflast year following one device-related failure. After an extensiveinvestigation conducted by a third-party expert inmedical device retrievals and the Impliant Research and Development team, itwas determined that device misalignment coupled with excessive shear loadingcaused the failure. As a result, Impliant has made a few minor design andmanufacturing changes to the internal components of the TOPS(TM) device thatallow it to better withstand high shear loads and misalignment while notaffecting its range of motion.
"I am pleased with the changes Impliant has made to the TOPS(TM) System,"said Mr. Sutcliffe. "I feel the device is now even better suited to stabilizethe spinal segment after performing the wide decompression that my severelystenotic patients require. However, it should be noted that all of my patientswith the original TOPS(TM) design continue to do extremely well, some of whichhave reached 12 months post-op."
Marcus Klarl, Vice President of European Clinical Affairs for Impliant,stated, "We are pleased to resume our TOPS(TM) clinical activities outside theUnited States and build upon the excellent outcomes generated to date by Mr.Sutcliffe and our other TOPS(TM) investigators."
The TOPS(TM) single and multi-level family of products have been implantedin over 80 patients in Brazil, South Africa, Belgium, Turkey, Israel, Germanyand the United Kingdom. The company also recently received FDA approval torestart its TOPS(TM) IDE clinical study in the United States.
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.Impliant obtained CE Mark approval for the TOPS(TM) System on June 1, 2006.
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 to January 2005. Impliant is also developing several next-generation and multi-level technologies to further increase its addressablemarket. Impliant is headquartered in Princeton, NJ with research facilitieslocated in Ramat Poleg, Israel. Shareholders include Elron ElectronicIndustries Ltd. (Nasdaq, TASE: ELRN). For more information about Impliant,please visit http://www.impliant.com.
SOURCE Impliant, Inc.
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