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LEESBURG, Va.–(BUSINESS WIRE)–K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ALEUTIAN^® Spacer Systems as intervertebral body fusion devices. The ALEUTIAN family of five different systems offers a full array of anatomically designed PEEK-OPTIMA^® interbody options, including the Anterior-Lumbar Interbody Fusion (ALIF), Small-Anterior (Cervical), Posterior-Lumbar Interbody Fusion (PLIF), Anatomically Narrow (AN), and Transforaminal-Lumbar Interbody Fusion (TLIF).

ALEUTIAN features radiolucent properties which have the potential to increase visualization of bone graft, while allowing for more accurate fusion assessment. In addition, the elastic modulus, a physical property of the material, more closely matches that of cortical bone for load sharing with the potential to minimize stress shielding and enhance fusion results. The bulleted nose allows for easier insertion and distraction, and the self-retaining teeth can potentially provide post-operative stabilization of the implant.

According to Dr. Raphael Roybal, Orthopedic Spine Surgeon at the Savannah Spine Institute, “The ALEUTIAN family of interbody PEEK cages provides a reproducible bridge where successful arthrodesis crosses over to superior anatomical reconstruction.”

“FDA clearance for the ALEUTIAN Spacer Systems to be marketed as intervertebral body fusion devices provides surgeons with multiple surgical applications in the cervical and lumbar spine for the treatment of Degenerative Disc Disease (DDD) and Spondylolisthesis, as well as more complex applications,” stated Eric Major, K2M’s President and CEO. “The anatomically designed implants and differentiated surgical instruments facilitate and streamline surgical applications. The ALEUTIAN family of products complements our comprehensive product portfolio of best-in-class systems for treating all types of complex spinal pathologies.”

Globus Medical launched the COALITION ACDF Spacer System. The device combines a PEEK interbody spacer with a titanium alloy plate and two titanium alloy screws, and the company says the design “reduces procedural steps, minimizes retraction and lags the spacer to the vertebral endplates to compressively load the fusion area.”

Dr. Robert J. Banco, an Orthopaedic Spine Surgeon with The Boston Spine Group in Boston, Mass. said, “Unequivocally, COALITION(TM) offers my patients the best possible solution of current cervical stand alone fusion treatments. The selection of spacer footprints and screw offerings provide unparalleled options for the varying anatomies in my patient population. I have found the innovative delivery system and design minimizes intra-operative fiddle factor while saving time.”

“Providing my patients a zero-profile offering with minimized esophageal retraction while retaining the same biomechanical stability of the standard of care is extremely beneficial,” added Dr. Andrew Clavenna, an Orthopaedic Spine Surgeon with The Carrell Clinic in Dallas, Texas. “This allows my procedures to be less invasive and less disruptive, which may quicken recovery.”