�Globus Medical, Inc., the largest
privately held spinal implant manufacturing business in the world, proclaimed
that the first FLEXUS(TM) Interspinous Spacers have been implanted under an
Investigational Device Exemption ("IDE") of late granted to Globus by Dr.
Donald Johnson II and Dr. Rhett Murray.
The FLEXUS(TM) Spacer is placed with a unilateral approach between two
spiny processes with minimal perturbation to the surrounding muscle system
and tissue. FLEXUS(TM) is a unitary radiolucent implant that requires no
intra-operative assembly and a single incision to insert. It is
manufactured from PEEK radiolucent polymer rather than titanium to more
tight match the biomechanical properties of ivory and eliminate MRI
scatter.
"FLEXUS(TM) is the windup of utilizing surgeon input and
technology simplicity to create innovational technologies to treat spinal anesthesia
stenosis. The FLEXUS(TM) IDE reflects Globus' position as the world-wide
leader in the development of hind end motion preservation devices. We are
excited to start the clinical trial to develop strong supportive data for
the product," aforementioned Michael Boyer, Group Engineering Manager for
Interlaminar Fixation.
"The combination of a unilateral approach and a unitary plant makes
FLEXUS(TM) not only a more than efficient routine but likewise one that is less
traumatic to the affected role," said Dr. Donald Johnson II, a spine surgeon of
the Southeastern Spine Institute in Mt. Pleasant, S.C. "I am proud of with
the PEEK pattern as it will enable better radiographic follow-up and allow
me to monitor both the decompression and the adjacent anatomy."
After implanting the first FLEXUS(TM) device, Dr. Rhett Murray, a
brain surgeon of The Spine and Neurosurgery Center in Huntsville, Ala.,
aforesaid, "The surgical technique and approach was very straightforward. The
simplicity of the FLEXUS(TM) design in distracting the stenotic segment may
be good in treating this dreadful condition. We are excited to
participate in this IDE."
The 340 patient prospective, randomised FLEXUS(TM) IDE study will seek
to prove comparison with the X-Stop device over the two year study period.
The study will involve patients that are over 50 years old world Health Organization may benefit
from the decompression provided by the FLEXUS(TM) gimmick, at up to 20
clinical sites across the United States.
About Globus Medical, Inc.
Globus Medical, Inc. is the largest in private held spinal anesthesia implant
manufacturer in the world. Based in Audubon, Pa., the privately held
company was founded in 2003 by an experienced team of spine professionals
with a shared vision to create products that enable vertebral column surgeons to
employ both fusion and non-fusion solutions to promote healing in patients
with spinal disorders. Globus Medical has a full portfolio of spinal anaesthesia fusion
products, burgeoning initiatives in biomaterials development and minimally
invasive approaches, and is among the world leaders in the evolution of
motion sparing technology. Additional information can be accessed at
http://www.globusmedical.com.
Globus Medical, Inc.
http://www.globusmedical.com
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