Impliant Restarts European Clinical Activities for Patented TOPS(TM) Spine System
June 26 2008 - 8:00AM
PR Newswire (US)
PRINCETON, N.J., June 26 /PRNewswire/ -- Impliant, Inc., a
developer of novel spine arthroplasty alternatives to fusion
surgery, today announced that it has resumed European clinical
activities on its TOPS(TM) System, a Total Posterior Arthroplasty
device designed to treat spinal stenosis with or without facet
arthrosis and spondylolisthesis. The procedure was performed by the
Lead Clinician of the London Spine Clinic, Mr. John C. Sutcliffe,
MB ChB, FRCS. (Logo:
http://www.newscom.com/cgi-bin/prnh/20080527/NETU060LOGO ) Impliant
had voluntarily suspended all clinical activities in September of
last year following one device-related failure. After an extensive
investigation conducted by a third-party expert in medical device
retrievals and the Impliant Research and Development team, it was
determined that device misalignment coupled with excessive shear
loading caused the failure. As a result, Impliant has made a few
minor design and manufacturing changes to the internal components
of the TOPS(TM) device that allow it to better withstand high shear
loads and misalignment while not affecting 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 stabilize the spinal segment after performing the wide
decompression that my severely stenotic patients require. However,
it should be noted that all of my patients with the original
TOPS(TM) design continue to do extremely well, some of which have
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 the United 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 implanted in
over 80 patients in Brazil, South Africa, Belgium, Turkey, Israel,
Germany and the United Kingdom. The company also recently received
FDA approval to restart its TOPS(TM) IDE clinical study in the
United States. 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. 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 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 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. (NASDAQ:ELRNTASE:ELRN). For more
information about Impliant, please visit http://www.impliant.com/.
http://www.newscom.com/cgi-bin/prnh/20080527/NETU060LOGO
http://photoarchive.ap.org/ DATASOURCE: Impliant, Inc. CONTACT:
Todd Potokar, President & CEO, +1-609-779-6800, ; or Marcus
Klarl, Vice President, European Clinical Affairs, +491742323112, ,
both of Impliant, Inc. Web site: http://www.impliant.com/
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