AUDUBON, Pa., Aug. 15 /PRNewswire/ -- Globus Medical, Inc., the largest
privately held spinal implant manufacturer in the world, today announced
that the first FLEXUS(TM) Interspinous Spacers have been implanted under an
Investigational Device Exemption ("IDE") recently granted to Globus by Dr.
Donald Johnson II and Dr. Rhett Murray.
The FLEXUS(TM) Spacer is placed with a unilateral approach between two
spinous processes with minimal disruption to the surrounding musculature
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
closely match the biomechanical properties of bone and eliminate MRI
scatter.
"FLEXUS(TM) is the culmination of utilizing surgeon input and
engineering simplicity to create innovative technologies to treat spinal
stenosis. The FLEXUS(TM) IDE reflects Globus' position as the worldwide
leader in the development of posterior motion preservation devices. We are
excited to begin the clinical trial to develop strong supportive data for
the product," said Michael Boyer, Group Engineering Manager for
Interlaminar Fixation.
"The combination of a unilateral approach and a unitary implant makes
FLEXUS(TM) not only a more efficient procedure but also one that is less
traumatic to the patient," said Dr. Donald Johnson II, a spine surgeon of
the Southeastern Spine Institute in Mt. Pleasant, S.C. "I am pleased with
the PEEK design 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
neurosurgeon of The Spine and Neurosurgery Center in Huntsville, Ala.,
said, "The surgical technique and approach was very straightforward. The
simplicity of the FLEXUS(TM) design in distracting the stenotic segment may
be beneficial in treating this painful condition. We are excited to
participate in this IDE."
The 340 patient prospective, randomized FLEXUS(TM) IDE study will seek
to prove equivalence with the X-Stop device over the two year study period.
The study will involve patients that are over 50 years old who may benefit
from the decompression provided by the FLEXUS(TM) device, at up to 20
clinical sites across the United States.
About Globus Medical, Inc.
Globus Medical, Inc. is the largest privately held spinal 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 spine 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 fusion
products, burgeoning initiatives in biomaterials development and minimally
invasive approaches, and is among the world leaders in the development of
motion sparing technology. Additional information can be accessed at
http://www.globusmedical.com.
SOURCE Globus Medical, Inc.
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Related links:
http://www.globusmedical.com
CONTACT:
Sara Brown Meehan of Globus Medical, Inc.,
+1-202-286-1995, sbmeehan@levick.com
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