VertiFlex Commercially Releases Superion(TM), a Percutaneously Delivered Interspinous Spacer
VertiFlex Inc., a privately-held medical device company, has
announced the commercial release of the Superion(TM) Interspinous
Spacer to countries outside the USA. The Superion implant is placed
percutaneously between the spinous processes without the need to cut
paraspinal muscles. It is primarily designed to offer relief from
neurogenic intermittent claudication and leg pain commonly associated
with spinal stenosis. The company received a CE mark for Superion in
2007 and has been clinically testing the device at several centers
outside the U.S. for the last several months. The product is currently
not approved for use in the U.S.
The Superion Interspinous Spacer fundamentally changes the
treatment paradigm for lumbar spinal stenosis and other indications of
benefit by offering a less invasive surgical alternative. Unlike all
other interspinous spacers currently on the market, the Superion
surgical technique does not require damage or harm to any of the
anatomical elements. A small incision is made posteriorly to the
midline and the implant is delivered through a small cannula. The
entire surgery is performed under local anesthesia and the average
surgery time has been 25 minutes or less.
Dr. Reuven Gepstein, Director of the National Unit of Spine
Institute, Israel, said, "I have implanted 15 Superions to date and am
very impressed with the early results. I have documented substantially
reduced pain scores in my patients and have had no associated
complications to report." Dr. Gepstein went on to say, "The benefit of
not cutting any muscle or ligament during implantation should result
in higher efficacy and lower complication rates for patients. The
Superion procedure is easily performed under local anesthesia, which
enables me to treat patients that are not candidates for general
anesthesia."
"We are excited to be releasing such a strong product offering to
markets outside the U.S. Patients are clearly benefiting from
interspinous spacer devices and we can now offer a product that is
truly superior in both efficacy and safety to the current offerings,"
said VertiFlex CEO Keegan Harper.
VertiFlex is in the process of initiating a U.S. IDE trial for the
Superion and anticipates starting the trial in quarter one of 2008.
About VertiFlex
VertiFlex Inc. is headquartered in San Clemente, California.
Founded in 2005, the company is a venture-backed medical device
company dedicated to the development and advancement of minimally
invasive and motion preservation technologies for disorders of the
spine. VertiFlex is committed to delivering advanced products that
transform patient outcomes focusing on technologies that benefit both
the surgeon and patient. For information regarding the Superion
Interspinous Spacer System, please contact Kathryn Larson, Marketing
Manager, (949) 940-1400 or info@vertiflexspine.com.