PREMIA SPINE LAUNCHES TOPS IDE STUDY (Orthopedics This Week)
Philadelphia, Pennsylvania-based Premia Spine, Ltd. has announced the launch of its FDA pivotal study of its new TOPS System. The first surgery was performed by Steven DeLuca, M.D. of the Orthopedic Institute of Pennsylvania. The new TOPS device has been in commercial use in Europe for over five years.
“I am very pleased with the ease of the procedure and the immediate post-operative result,” stated Dr. DeLuca, in the company’s July 20, 2017 news release. Dr. DeLuca performed the surgery at Pinnacle Westshore Hospital in Harrisburg, Pennsylvania.
“We are excited about the opportunity to provide U.S. 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,” said Premia Spine CEO Ron Sacher.
The Premia Spine news release indicated, “The IDE study will take place in 30 institutions and enroll 330 subjects. Patients will be randomized to either the TOPS System or lumbar fusion (i.e., an interbody cage plus screws and rods), with a 67% likelihood of receiving the TOPS device.”
Sacher told OTW, “There wasn’t one particular challenge in setting up the new TOPS IDE study. It’s been a process that began with the redesign of the TOPS device in 2011 to make it smaller and simpler to implant.”
“That activity has paid off in Europe, where we have been in commercial use for over five years with excellent results. We worked closely with the FDA on designing the protocol. The goal posts have definitely moved since the 2006 IDE [investigational device exemption] vintage studies pursued by Impliant, Facet Solutions, Archus, and Stabilimax.”
“My sense is that the FDA would like to have spinal stenosis patients treated with non-instrumented surgery or maximum a Coflex. For the more severe patients with degenerative spondylolisthesis and spinal stenosis—where there is a need for a more thorough decompression and segmental restabilization—an instrumented fusion is warranted. And that’s where we fit in.”
“Once we nailed down the protocol, I went out to recruit sites for the study. The reception has been beyond my most optimistic expectations. Surgeons understand the need for a device that can treat this patient population without sacrificing the disc and segmental motion.”
“We have approval for 30 sites. The FDA wanted a very homogeneous patient population, with a heterogeneous surgeon investigator group. We have neuro and ortho surgeons—single practitioners and large groups—private practice and university settings. We have a few more slots available and welcome motivated surgeons with the clinical interest and infrastructure to join us.”