среда, 13 апреля 2011 г.

Medtronic Announces Launch Of X-Stop® Peek IPD® System For U.S. Patients Suffering From Symptoms Of Lumbar Spinal Stenosis

Medtronic, Inc. (NYSE: MDT), today announced the
U.S. launch of the X-STOP PEEK IPD System, the first interspinous process
decompression (IPD) device approved by the U.S. Food and Drug Administration
(FDA) that offers a PEEK-Bone interface for treating the symptoms of lumbar spinal
stenosis (LSS). LSS is the most common reason for back surgery in people over the age
of 65 in the United States. i


Polyetheretherketone (PEEK) polymer, a biomaterial widely accepted for spinal
applications, provides several benefits such as biocompatibility and radiolucency
(allows the passage of X-rays). Medtronic's launch of the PEEK version, the second
generation of the X-STOP system, gives spine surgeons the option of using this material
in IPD procedures.


The X-STOP PEEK system is a minimally invasive treatment of the symptoms of LSS.
This degenerative condition can cause compression of the spinal cord and nerves in the lower back, leading to back and leg pain or numbness that can affect mobility. An
estimated 875,000 Americans are diagnosed with LSS each year, and more than two
million Americans currently suffer from this disease. ii


"We are extremely excited to offer the 3,200 U.S. surgeons trained so far on the X-STOP
procedure the added benefits of the X-STOP PEEK system," said Robert White,
president of Kyphon products in the Spinal and Biologics business at Medtronic. "Many
surgeons will welcome the properties of PEEK, the elliptical shape of the new device,
and the addition of a 16 mm size implant to our X-STOP product line."


The X-STOP PEEK system provides benefits comparable to the original X-STOP system,
which was launched in the U.S. in 2006, and also includes changes in material, shape
and available sizes.


• In the new system, the body of the device that is implanted between the spinous
processes to prevent the pinching of the nerves is composed of a PEEK outer ring,
with the remainder of the device made of titanium alloy. The original product is
made completely of titanium alloy.


• The X-STOP PEEK implant has been designed to be more elliptical than the firstgeneration
X-STOP device. This shape increases the contact area with bone by 30
percent compared to an implant of circular cross section. iii There is a broader loadbearing
surface for distributing loads to the spinous processes, thereby decreasing contact pressures.


Medtronic has also extended its product offering of X-STOP implant sizes with the
addition of the 16 mm implant in the PEEK system. This larger implant size has
been requested by spine surgeons for some of their patients.


The X-STOP PEEK system has been in clinical use in Europe since 2004. St. Francis
Medical Technologies, the original developer of the X-STOP system, first launched the
PEEK version, which was approved for European markets in March 2004. St. Francis
Medical Technologies was acquired in January 2007 by Kyphon, which was acquired by
Medtronic in November 2007. The FDA approved the X-STOP PEEK system in August
2006.















Medtronic will continue to offer both the titanium and PEEK versions of the X-STOP
system to accommodate the preferences of U.S. spine surgeons.


The X-STOP PEEK system will be introduced to the spine surgeon community at this
year's 23 rd Annual Meeting of the North American Spine Society scheduled Oct. 14 - 18
in Toronto.


More information about the X-STOP IPD system can be found at xstopspacer


About the Spinal and Biologics Business at Medtronic


The Spinal and Biologics business is based in Memphis, Tenn. and operates its
KYPHON ® Balloon Kyphoplasty, X-STOP ® IPD ® , and disc disease diagnostics business
in Sunnyvale, Calif. and Brussels, Belgium. It is the global leader in today's spine
market and is committed to advancing the treatment of spinal conditions. The Spinal
and Biologics business works with world-renowned surgeons, researchers and
innovative partners to offer state-of-the-art products and technologies for neurological,
orthopaedic, dental and spinal conditions. Medtronic is committed to developing
affordable, minimally-invasive procedures that provide lifestyle-friendly surgical
therapies. More information about the company and its treatment therapies can be
found here
and the following patient-education Web sites, back, iscoliosis,
maturespine and necksurgery.


About Medtronic


Medtronic, Inc., headquartered in Minneapolis, is the global
leader in medical technology - alleviating pain, restoring health and extending life for
millions of people around the world. medtronic


Any forward-looking statements are subject to risks and uncertainties such as those
described in Medtronic's Annual Report on Form 10-K for the year ended April 25, 2008.
Actual results may differ materially from anticipated results.


KYPHON® Balloon Kyphoplasty incorporates technology developed by Gary K. Michelson, M.D.


i Ciol MA, Deyo RA, Howell E, Kreif S. An assessment of surgery for spinal stenosis: time trends, geographic
variations, complications, and reoperations. J Am Geriatr Soc. 1996; 44:285-290.

ii National Hospital Discharge Survey (NHDS), National Ambulatory Medical Care Survey (NAMCS), and National
Hospital Ambulatory Medical Care Survey (NHAMCS)

iii X STOP® IPD® System Summary of Safety and Effectiveness, 2005.

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