Wenzel Spine Receives FDA Clearance Expanding Clinical Indications for primaLOK SP
22 Aug 2023
AUSTIN, Texas--(BUSINESS WIRE)-- Wenzel Spine, Inc., a medical technology company specializing in the development of a minimally invasive surgical technology and diagnostic platform for the treatment of spinal disorders, is pleased to announce the recent FDA clearance for their primaLOK SP System. This achievement marks a significant advancement in spinal fusion technology, offering surgeons and patients a highly effective and reliable solution for spinal stabilization.
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The primaLOK SP System combines cutting-edge engineering with patient-focused design to provide a comprehensive solution for spinal fusion procedures. With this clearance, Wenzel Spine continues its commitment to delivering high-quality products that enhance surgical outcomes and improve patient lives. The new clinical indications from the FDA clearance allow for the primaLOK SP to be used at multiple levels and to treat patients with lumbar spinal stenosis.
“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,” commented, William E. Wilson, CEO of Wenzel Spine.
Key features and benefits of the primaLOK SP System include:
1. Innovative Locking Mechanism: The primaLOK SP System boasts a unique locking mechanism that ensures secure stabilization, reducing the risk of migration and providing stability during the critical fusion process.
2. Precision and Versatility: Engineered with precision, the unique polyaxial primaLOK SP System offers a high degree of flexibility to accommodate various patient anatomies and offers surgeons the ability to tailor each procedure to individual needs.
3. Minimized Tissue Disruption: The system’s minimally invasive approach minimizes tissue disruption, potentially leading to reduced postoperative pain, shorter hospital stays, and quicker patient recovery.
4. Enhanced Radiographic Visibility: The device design prioritizes enhanced radiographic visibility, allowing surgeons to confidently assess implant placement and fusion progress.
Dr. Charles Gordon, MD, a renowned neurosurgeon and founder of Texas Spine & Joint Hospital in Tyler, TX, stated, “The primaLOK SP System is a significant advancement for 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.”
The clearance of the primaLOK SP System marks a milestone for Wenzel Spine, underscoring their dedication to advancing spinal healthcare and transforming the landscape of spinal fusion procedures. primaLOK SP is commercially available in the US.
For more information about the primaLOK SP System and other groundbreaking procedural solutions from Wenzel Spine, please visit their website at .
About Wenzel Spine:
Wenzel Spine, Inc. is a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders. Headquartered in Austin, TX, Wenzel Spine is focused on delivering surgical solutions that improve the overall quality of spine care by simplifying procedures and reducing recovery time. Wenzel Spine seeks to improve patient quality of life by designing and producing devices of the highest quality to support our surgeon clients in the care and treatment of their patients.
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