New Technology to Treat Lumbar Spinal Stenosis

The Helifix is a non-fusion interspinous device designed to provide relief from the symptoms of LSS by providing flexion in the posterior elements; the Helifuse is similar in design to Helifix, but will be a fusion device that may be combined with percutaneous spinal fixation. Both devices work by preventing extension at the spinal level of interest, thus reducing symptoms. The Helifix device is self-distracting and can be made from a variety of materials including titanium, polyaryletheretherketone (PEEK), or bone, and is designed so that it can be inserted and removed percutaneously. It can be inserted by spine surgeons and interventional radiologists, and the procedure can be performed on an inpatient or outpatient basis. Because of the design and the different materials that can be used, the device could be used for both fusion and nonfusion procedures.

"It is estimated that 37% of surgeries on patients age 65 or older are for spinal stenosis,” said Dirk Kuyper, president and CEO of Alphatec Spine. "Helifix and Helifuse will allow surgeons to treat the older patient with spinal stenosis in a minimally invasive manner. These products complement our growing portfolio of aging spine products.”

"Neural passageways are compromised by aging and exacerbated by extension in patients with spinal stenosis,” said James J. Yue, M.D., a member of Alphatec Spine's scientific advisory board and an associate professor at Yale University (New Haven, CT, USA). "Clinical observations of patients show they experience relief in their symptoms with flexion. So it stands to reason that by preventing extension at the level of interest, symptoms may be reduced or eliminated.”

LSS arises from age-related changes to the facets and the intervertebral disc that can eventually lead to a reduction in the patient's quality of life. More than two million people 65 years and older in the United States were diagnosed with spinal stenosis in 2008. There were more than 145,000 of these procedures performed on LSS patients aged 65 years and older in 2008, and it is estimated that this number will grow to over 160,000 procedures by the year 2012. Traditionally, lumbar spinal stenosis has been treated with a laminectomy.

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