Premia Spine has secured US Food and Drug Administration approval for its pivotal study of the new Tops system.
“We are excited about the opportunity to provide USA patients with access to the only posterior arthroplasty device for degenerative grade I spondylolisthesis and spinal stenosis, with thickening of the ligament or scarring of the facet capsule,” says Ron Sacher, chief executive officer of Premia Spine.
The new Tops device, with a 30% smaller footprint and a simpler surgical technique to the original device, has been in commercial use in Europe for over five years.
The Investigational Device Exemption study is planned to take place in 30 institutions and enroll 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.
The study’s lead investigator is Dom Coric, chief of neurosurgery, at Carolinas Medical Center, Charlotte, USA. Clinicians who have received approval or are in the process of securing Institutional Review Board (IRB) approval include Josh Ammerman and Josh Wind (Sibley Hospital, Washington, DC, USA), Neel Anand and Hyun Bae (Cedars Sinai, Los Angeles, USA), Steve DeLuca (Orthopedic Institute of Pennsylvania, Harrisburg, USA), Jason Huang (Baylor Scott & White), Armen Khachatryan (The Disc Replacement Center at Jordan Valley Medical Center, West Jordan, USA), Andy Kranenburg (Providence Medford Medical Center, Medford, USA), Scott Leary (Scripps Health, San Diego, USA), Ali Mesiwala (Southern California Center for Neuroscience and Spine, Pomona, USA), Kent New, Steve Pirris, Eric Nottmeier, and Ali Chahlavi (St Vincent’s Medical Center, Bridgeport, USA), Pierce Nunley (Spine Institute of Louisiana, Shreveport, USA), Rick Sasso (Indiana Spine Group, Carmel, USA), Bill Smith (Western Regional Brain & Spine, Las Vegas, USA), Don Whiting (Allegheny Health Network, Pittsburgh, USA), Phil Yuan (Memorial Long Beach Hospital, Long Beach, USA) and Jim Zucherman, Ken Hsu, and Dimitriy Kondrashov (St Mary’s Medical Center, West Palm Beach, USA).
According to a press release, other spine research centers are currently preparing their IRB submissions to join the study. Clinical sites will be measuring Oswestry Disability Index, Visual Analogue Scale for pain, 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.