Karma®, an innovative, metal-free, cortico-pedicular posterior fixation device, is the first spine fixation device to utilize the dense cortico-pedicular corridor, providing an alternative to traditional posterior fixation methods.
The unique design of Karma’s curved drill creates an arcuate tunnel through the pedicle and cortical anchor points- IAP, SAP and Lamina, utilizing the densest cortical bone.
The Karma PEEK device is implanted through the tunnel and then tensioned for fixation.
Karma’s instrument set makes accessing the cortico-pedicular corridor safe and reproducible with the use of a proprietary curved drill. A safety study of the drill was
conducted, and the results were recently published in the World Neurosurgery journal entitled Metal-Free Cortico-Pedicular Device for Supplemental Fixation in Lumbar Interbody Fusion by Pierce D. Nunley, MD, et al.
The safety and reproducibility were tested in a cadaver study with four specimens, ranging in age from twenty to eighty-five years old. Nine spine surgeons with no prior
experience using Karma performed the procedure on the specimens. The surgeons used Karma’s curved drill to create 35 tunnels at all lumbar levels in the specimens and then, the tunnels were evaluated using 3D fluoro. The outcome of the study reported no breaches of any kind and the drill averages about 7mm of bone stock between the anterior cortex and the spinal canal.
The paper concluded, “Overall, these results suggest that the curved drill utilized during cortico-pedicular fixation can reliably and safely create a pathway to facilitate circumferential fixation across the facet joints, and with a consistent margin of safety for the intervertebral foramen and spinal canal in the lumbar spine.”
Read the paper for more details about the safety study and other preclinical and clinical results at https://bit.ly/karmapaper.
More on Karma
Karma is a metal-free cortico-pedicular posterior fixation system. Karma provides circumferential, cortical fixation, which provides comparable stability to pedicle screw systems, with less stress shield of the anterior column. The Karma procedure preserves patients’ native posterior anatomy and is performed using a single tray of instruments and a universal PEEK strap implant. Karma’s extremely low-profile implant compares favorably versus larger metal posterior fixation devices. Karma is part of Spinal Elements’ MIS Ultra® suite of products that are intended to address the unintended consequences of spine surgery. Learn more about Karma at https://bit.ly/karmamis.
See Karma for yourself – Register for an in-office demonstration at https://bit.ly/karmaofficedemo.
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