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Medtronic introduces PEEK-based interspinous process decompression device

Medtronic : 15 October, 2008  (New Product)
Medtronic has announced the US launch of the X-STOP PEEK IPD System, the first interspinous process decompression (IPD) device approved by the US 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 USA.

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.

“We are extremely excited to offer the 3,200 US 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 US 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 first-generation X-STOP device. This shape increases the contact area with bone by 30 percent compared to an Implant of circular cross section. There is a broader load-bearing 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. The 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 US spine surgeons.
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