Impliant Launches Less-Invasive Version of Patented TOPS(TM) Spine System
July 17 2008 - 11:07AM
PR Newswire (US)
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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20080527/NETU060LOGO ) 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/.
http://www.newscom.com/cgi-bin/prnh/20080527/NETU060LOGO
http://photoarchive.ap.org/ DATASOURCE: Impliant, Inc. CONTACT:
Todd Potokar, President & CEO, , or Andrew Shepherd, Vice
President, Sales & Marketing, , both of Impliant, Inc.,
+1-609-779-6800 Web site: http://www.impliant.com/
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