Premia Spine has launched US Food and Drug Administration (FDA) pivotal study of an updated version of its Tops system. According to chief executive officer Ron Sacher, this is “the only posterior arthroplasty device for degenerative grade I spondylolisthesis and spinal stenosis, with thickening of the ligament or scarring of the facet capsule.”
The new Tops device, with a 30% smaller footprint and a simpler surgical technique from the original device, has been in commercial use in Europe for over five years.
The first surgery was performed by Steven DeLuca of the Orthopedic Institute of Pennsylvania. The Tops procedure was performed at Pinnacle Westshore Hospital in Harrisburg, USA.
“I am very pleased with the ease of the procedure and the immediate post-operative result,” states DeLuca.
The investigational device exemption (IDE) study will take place in 30 institutions and enrol 330 subjects. Patients will be randomised to either the Tops System or lumbar fusion (ie., an interbody cage plus screws and rods), with a 67% likelihood of receiving the Tops device.
Clinical sites will be measuring Oswestry Disability Index, Visual Analogue Scale, neurologic function, device integrity, reoperation rates and other quantitative outcomes for the study device and the fusion control. “Our goal is to establish the superiority of the Tops system versus traditional lumbar spinal fusion,” explains Sacher.