05.28.13
Austin, Texas-based Wenzel Spine has rolled out its zero-profile, standalone Varilift Cervical (Varilift-C) expandable interbody fusion system for sale in the United States. The system has held CE mark approval since November 2010. The U.S. Food and Drug Administration (FDA) cleared the device in February this year.
Varilift-C is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level. The device is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 (in the neck) disc levels using autograft bone. Varilift-C may be used with or without supplemental fixation, according to Wenzel.
“We are pleased that the FDA granted clearance to market Varilift-C,” said Chad Neely, CEO of Wenzel. “This will be the only expandable cervical interbody fusion device available which may be used without anterior plating, integrated screws or other types of supplemental fixation. VariLift-C represents a true zero-profile, standalone options for surgeons to use in [anterior cervical discectomy and fusion (ACDF)] cases. Varilift-C is a proven standalone solution, which is essential for today’s surgeons to simplify ACDF procedures, improve clinical outcomes for patients, and reduce overall cost to the healthcare system. Wenzel Spine and Varilift are in the unique position to be able to offer standalone expandable solutions for the entire segmented spine via ACDF, posterior lumbar interbody fusion (LIF), transforaminal LIF and anterior LIF approaches.”
Wenzel Spine offers minimally invasive technology to treat disc herniations, spinal stenosis and spondylolisthesis.
Varilift-C is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level. The device is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 (in the neck) disc levels using autograft bone. Varilift-C may be used with or without supplemental fixation, according to Wenzel.
“We are pleased that the FDA granted clearance to market Varilift-C,” said Chad Neely, CEO of Wenzel. “This will be the only expandable cervical interbody fusion device available which may be used without anterior plating, integrated screws or other types of supplemental fixation. VariLift-C represents a true zero-profile, standalone options for surgeons to use in [anterior cervical discectomy and fusion (ACDF)] cases. Varilift-C is a proven standalone solution, which is essential for today’s surgeons to simplify ACDF procedures, improve clinical outcomes for patients, and reduce overall cost to the healthcare system. Wenzel Spine and Varilift are in the unique position to be able to offer standalone expandable solutions for the entire segmented spine via ACDF, posterior lumbar interbody fusion (LIF), transforaminal LIF and anterior LIF approaches.”
Wenzel Spine offers minimally invasive technology to treat disc herniations, spinal stenosis and spondylolisthesis.