Wenzel Spine secures FDA clearance to update indications for spinal fusion technology

Wenzel Spine secures FDA clearance to update indications for spinal fusion technology

Time Stamp: August 23, 2023 9:17 AM
Source Node: 2839952
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In the North America regions the number of Spinal Surgery Procedures performed was 1,046,477 in 2015 and is forecast to reach 2,315,491 in 2030. Credit: Natali _ Mis/Shutterstock

Texas-based company, Wenzel Spine has been granted an expanded FDA clearance for its primaLOK SP device to treat multiple spinal fusion procedures. .

The primaLOK SP system is a posterior lumbar spinous process fixation device which can work in conjunction with Wenzel Spine’s VariLift LX.

The primaLOK SP device touts a number of features and benefits which include a locking mechanism for stabilisation in the fusion process, minimised tissue disruption and enhanced radiographic visibility..

Wenzel Spine hailed the clearance as an achievement for the firm, stating itallows them to expand its treatment offering at various levels. William E. Wilson, CEO of Wenzel Spine said: “We are proud to receive FDA clearance to update the clinical indications for primaLOK SP. This achievement reflects our ongoing commitment to innovation and excellence in our spinal solutions. We believe this system will significantly contribute to improved patient outcomes through a less invasive approach.”

Dr. Charles Gordon, MD, neurosurgeon, and founder of Texas Spine & Joint Hospital praised the advancements that the primaLOK SP system brought to spinal fusion procedures.“Its versatile locking mechanism and patient-centric design truly set it apart. These expanded clinical indications will allow me to further incorporate this system into my practice and provide my patients with a higher level of care,” said Gordon.

GlobalData expects that throughto 2030, spinal fusion will be more popular in treating spinal stenosis as surgeons find spinal fusion to be an effective treatment for this condition. The market for expandable interbody cages will continue to exhibit growth as companies develop more effective expandable systems that improve bone anchoring and patient outcomes.

In the North America regions the number of Spinal Surgery Procedures performed was 1,046,477 in 2015 and is forecast to reach 2,315,491 in 2030.

Currently the device is only available commercially in the US.

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