Premia Spine launched an FDA pivotal study of the TOPS system, and the first procedure was performed in Pennsylvania.
Here are five things to know:
1. The Premia Spine TOPS study examines the TOPS device, which was designed to leave a 30 percent smaller footprint and be a simpler technique than the company's original device. Surgeons in Europe have had access to Premia Spine's original device for more than five years.
2. The IDE study will include 30 institutions and enroll 330 patients. The patients will either undergo surgery with the TOPS System or lumbar spinal fusion; patients are randomly placed into one group or the other with a 67 percent likelihood of undergoing surgery with the Premia device.
3. Patients will provide their Oswestry Disability Index, Visual Analog Scale and neurologic function scores to compare between the two groups. Study authors will also examine reoperation rates and quantitative outcomes.
4. Steven DeLuca, MD, of Camp Hill, Pa.-based Orthopedic Institute of Pennsylvania, performed the first procedure in the study at Harrisburg, Pa.-based Pinnacle Westshore Hospital.
5. The Premia TOPS System has been used in 1,000 patients.