PRINCETON, N.J., June 26 NJ-Impliant-TOPS
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.
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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, TASE: ELRN). For more information about Impliant,
please visit http://www.impliant.com.
SOURCE Impliant, Inc.
