- Aurora Spine Corporation (ASG) announces first patients in Multicenter Study of the ZIP® Interspinous Fixation Device
- The REFINE Screwless™ ZIP Study is a multi-center, randomized trial evaluating the Aurora Spine ZIP® Direct Decompression
- The ZIP® device is an alternative to more invasive traditional spinal surgery
- 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
- Aurora Spine is focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies
- Aurora Spine Corporation (ASG) is trading at C$0.64 at 10:56 am PT
Aurora Spine Corporation (ASG) has enrolled its first patients into a study of its ZIP® Interspinous Fixation device.
The REFINE Screwless™ ZIP Study is a multi-center, randomized trial evaluating the Aurora Spine ZIP® Direct Decompression.
Aurora Spine anticipates studies to take place in 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 Chief Executive Officer 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,” added Northcutt.
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.”
“The purpose of this study is to develop the highest level of scientific evidence bringing this landmark therapy to the forefront,” concluded Falowski.
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 with 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.
Aurora Spine is focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies.
Aurora Spine Corporation (ASG) is trading at C$0.64 at 10:56 am PT.
