First FLEXUS(TM) Interspinous Spacer Surgeries for IDE Clinical Trial
The FLEXUS(TM) Spacer is placed with a unilateral approach between twospinous processes with minimal disruption to the surrounding musculature andtissue. FLEXUS(TM) is a unitary radiolucent implant that requires nointra-operative assembly and a single incision to insert. It is manufacturedfrom PEEK radiolucent polymer rather than titanium to more closely match thebiomechanical properties of bone and eliminate MRI scatter.
"FLEXUS(TM) is the culmination of utilizing surgeon input and engineeringsimplicity to create innovative technologies to treat spinal stenosis. TheFLEXUS(TM) IDE reflects Globus' position as the worldwide leader in thedevelopment of posterior motion preservation devices. We are excited to beginthe clinical trial to develop strong supportive data for the product," saidMichael Boyer, Group Engineering Manager for Interlaminar Fixation.
"The combination of a unilateral approach and a unitary implant makesFLEXUS(TM) not only a more efficient procedure but also one that is lesstraumatic to the patient," said Dr. Donald Johnson II, a spine surgeon of theSoutheastern Spine Institute in Mt. Pleasant, S.C. "I am pleased with the PEEKdesign as it will enable better radiographic follow-up and allow me to monitorboth the decompression and the adjacent anatomy."
After implanting the first FLEXUS(TM) device, Dr. Rhett Murray, aneurosurgeon of The Spine and Neurosurgery Center in Huntsville, Ala., said,"The surgical technique and approach was very straightforward. The simplicityof the FLEXUS(TM) design in distracting the stenotic segment may be beneficialin treating this painful condition. We are excited to participate in thisIDE."
The 340 patient prospective, randomized FLEXUS(TM) IDE study will seek toprove equivalence with the X-Stop device over the two year study period. Thestudy will involve patients that are over 50 years old who may benefit fromthe decompression provided by the FLEXUS(TM) device, at up to 20 clinicalsites across the United States.
About Globus Medical, Inc.
Globus Medical, Inc. is the largest privately held spinal implantmanufacturer in the world. Based in Audubon, Pa., the privately held companywas founded in 2003 by an experienced team of spine professionals with ashared vision to create products that enable spine surgeons to employ bothfusion and non-fusion solutions to promote healing in patients with spinaldisorders. Globus Medical has a full portfolio of spinal fusion products,burgeoning initiatives in biomaterials development and minimally invasiveapproaches, and is among the world leaders in the development of motionsparing technology. Additional information can be accessed atwww.globusmedical.com.
SOURCE Globus Medical, Inc.
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