Calif.–(BUSINESS WIRE)–VertiFlex®, Inc., a
leading innovator of minimally invasive and motion preserving spinal surgery
technologies, today announced the completion of enrollment in its pivotal IDE
clinical trial of the Superion® Interspinous Spacer (ISS). The results of the
Superion trial will form the basis for a PMA approval application to the U.S.
Food and Drug Administration (FDA).
“Our Superion IDE study is the largest ever FDA clinical
trial for lumbar spinal stenosis with 470 patients enrolled,” said Earl R.
Fender, President and Chief Executive Officer of VertiFlex, Inc. “Completion of
enrollment in this pivotal trial marks a significant milestone for minimally invasive spine surgery. We greatly appreciate the
invaluable support from each of our clinical investigator teams across the
country, who helped VertiFlex achieve our enrollment goal ahead of schedule,
and brings us closer to the day when hundreds of thousands of patients
suffering from lumbar spinal stenosis will have access to Superions
differentiated, advanced, and least invasive technology.”
The Superion IDE trial is a prospective, multi-center,
controlled clinical trial studying the safety and efficacy of the Superion ISS
compared to control arm X-STOP® IPD® in healthy adults suffering from at least
six months of moderate lumbar spinal stenosis who have been unresponsive to
conservative care. The national trial is being conducted at 31 leading spine
surgery sites in the United
States. The study endpoint is the rate of
overall success at 24 months.
“Spinal stenosis can have a tremendous impact on a persons
mobility and physical activity. While there are treatment options available,
many patients want less invasive options for lower back and leg pain relief,” said Peter Whang, M.D.,
Associate Professor, Department of Orthopedics and Rehabilitation at Yale
University School of Medicine and a principal investigator in the Superion
trial. “The Superion ISS from VertiFlex may offer a less invasive, motion
preserving solution to traditional spine surgery. We are excited to complete
enrollment of the trial, and over the next 24 months we will be further
evaluating the data for submission to the FDA.”
Spinal stenosis is the degenerative narrowing of the spaces
in the spine that can lead to spinal cord and/or nerve compression and is the cause of leg and back pain for
over 1.5 million Americans each year. A significant portion of these patients
are currently living with the limited pain relief received from existing
non-surgical treatments, and are strong candidates for a minimally invasive,
outpatient surgical option.
The Superion ISS was designed as an alternative to more
invasive traditional spinal surgery. The Superions minimally invasive surgical
technique is performed through a single, half-inch skin incision. Once in
place, the device is intended to act as a support column to open the
passageways that contain the spinal cord and nerve roots. This may reduce the
compression on the nerves, resulting in potential pain relief in the leg, groin
and buttocks, and the return to a more active lifestyle.
About VertiFlex, Inc.
VertiFlex is a privately held medical device company dedicated to the
advancement of minimally invasive and motion preserving technologies for
disorders of the spine. Founded in 2005 and headquartered in San Clemente, CA., VertiFlex has developed
the Superion Interspinous Spacer System. The Superion ISS is the most advanced
and least invasive interspinous spacer available, and has been implanted in
over 2,000 patients around the world, receiving CE mark in 2007. The companys
goal is to establish Superion as the standard of care for the minimally invasive
treatment of lumbar spinal stenosis. Current investors include Aberdare
Ventures, Alta Partners, New Enterprise Associates, and Thomas, NcNerney and
Posted by Sean Fenske, Editor-in-Chief, MDT