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

Main Category: Bones / Orthopaedics
Also Included In: Back Pain;  Medical Devices / Diagnostics
Article Date: 14 Oct 2008 - 9:00 PDT

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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 http://www.xstopspacer.com

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, http://www.back.com, http://www.iscoliosis.com, http://www.maturespine.com and www.necksurgery.com.

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. http://www.medtronic.com

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.