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 www.globusmedical.com.
CONTACT: Sara Brown Meehan of Globus Medical, Inc., +1-202-286-1995,
sbmeehan@levick.com
Web site: http://www.globusmedical.com/
