PREMIA SPINE LAUNCHES TOPS IDE STUDY (Orthopedics This Week)
more info on TOPS
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....
