PRINCETON, N.J., July 17 NJ-Impliant-TOPS-New
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. (Nasdaq & TASE: ELRN). For more information about
Impliant, please visit http://www.impliant.com.
SOURCE Impliant, Inc.
