Aurora Spine Begins ZIP Interspinous Fixation Device Trial

Aurora Spine Corporation announced the first patients have been enrolled into a pivotal multi-center study of its ZIP Interspinous Fixation device for patients suffering from back pain due to symptomatic degenerative disc disease.
 
The REFINE Screwless ZIP Study is a multi-center, randomized trial evaluating the Aurora Spine ZIP Direct Decompression. Aurora Spine anticipates up to 10 interventional spine and neuro Surgical sites throughout the US and expects to enroll approximately 100 patients.
 
The ZIP device is an alternative to more invasive traditional spinal surgery. The ZIP device’s minimally invasive surgical technique works through a single, small surgical cut. Once in place, the device acts as a fusion support column to open the passageways that contain the spinal cord and nerve roots. This procedure may reduce the compression on the nerves, resulting in potential pain relief in the leg, groin, and buttocks, and then return to a more active lifestyle.
 
“We appreciate all the support from the stellar group of physicians across the country to bring this pivotal ZIP multicenter study to fruition and ahead of schedule,” said Trent J. Northcutt, president and CEO of Aurora Spine. “The enrollment in this meaningful study marks a significant milestone for minimally invasive spine surgery. In addition, we appreciate the invaluable support from each of our clinical investigator teams across the country, who helped Aurora achieve our enrollment goals.”
 
According to nationally recognized functional neurosurgeon Dr. Steven Falowski, who enrolled the first patient, “Many of my patients suffering from lower back or leg pain could benefit from the ZIP minimally invasive outpatient treatment option that replaces traditional more invasive spinal decompression surgery commonly done with pedicle screws. I am very excited about the historical results and promising future of the ZIP Screwless procedure. I am proud to participate as a co-Principal Investigator in this groundbreaking multicenter study. The purpose of this study is to develop the highest level of scientific evidence bringing this landmark therapy to the forefront.”
 
Dr. Jason E. Pope, co-Principal Investigator in the study, a pain physician and anesthesiologist, highlighted that “the ZIP device procedure operationalizes the ability to perform a posterior interspinous fusion for those specially trained pain physicians, offering an additional minimally invasive option to remove pain and improve function in select patients suffering from degenerative disc disease accompanied by neurogenic claudication.”
 
The ZIP System was 510(k) cleared by the FDA in 2013 and has been commercially available in multiple sizes in the US since 2014. With more than 5,000 procedures already completed worldwide, the ZIP device is safe and effective in an outpatient setting. The ZIP device provides physicians the ability to remove targeted ligament, bone, and facet capsule material. This quick decompression involves minimal collateral tissue disruption and can also work under local anesthesia. A recent retrospective study demonstrated the ZIP device’s safety and effectiveness in the hands of interventional pain physicians.