Wenzel Spine has announced that the US Food and Drug Administration (FDA) has granted clearance for expanded clinical indications of its primaLOK SP system.
The Texas-based medical technology company said that the FDA nod for new clinical indications will allow the use of the system at multiple levels in lumbar spinal stenosis treatment.
According to Wenzel Spine, the clearance marks a major advancement in spinal fusion technology. It gives surgeons and patients an effective and dependable solution for spinal stabilisation, said the company, which develops minimally invasive surgical technology and diagnostic platform for spinal disorders.
Available commercially in the US, the primaLOK SP system integrates advanced engineering with patient-focused design with the intent to deliver a complete solution for spinal fusion procedures.
Wenzel Spine CEO William Wilson 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.”
The system has a locking mechanism that ensures secure stabilisation, thus lowering the risk of migration and providing stability throughout the critical fusion process.
According to the medical technology firm, the polyaxial primaLOK SP System presents a high degree of flexibility to surgeons for accommodating different patient anatomies. It also offers the ability to customise each procedure to individual requirements.
Wenzel Spine said that the system’s minimally invasive approach reduces tissue disruption. This possibly results in lowered postoperative pain, shorter hospital stays, and rapid patient recovery.
Additionally, its increased radiographic visibility enables doctors to assess implant placement and fusion progress confidently.
Texas Spine & Joint Hospital in Tyler, Texas founder and neurosurgeon Charles Gordon said: “The primaLOK SP System is a significant advancement for spinal fusion procedures.
“Its versatile locking mechanism and patient-centric design truly set it apart.”
