Michael Barbella, Managing Editor03.30.21
Aurora Spine Corporation has been given permission to study its back pain relief solution, receiving Institutional Review Board (IRB) approval for a multicenter study of the ZIP Interspinous Fixation device for patients suffering from symptomatic degenerative disc disease.
“This multicenter study will involve 100 patients with results expected this year. The study is designed to demonstrate reproducible outcomes in the real-world with attention to pain, function, and quality of life. We are excited to pursue this evidence-based pathway on the ZIP implant family that has already demonstrated worldwide success. The enthusiasm from the investigators has been outstanding,” said Michael A. Fishman, M.D., MBA., director of Research at the Center for Interventional Pain & Spine in Lancaster, Pa. “Site selection has commenced, and we are appreciative of all the support from our stellar group of physicians across the country to bring this pivotal technology to market. We believe this is the future of Ultra-Minimally Invasive Spine (u-MIS) procedures.”
The IRB is a U.S. Food and Drug Administration (FDA)-registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects. Under FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
"Aurora recently conducted an advanced training session and cadaver lab that introduced leading neurosurgical, orthopedic, and pain management physicians to the ZIP implant. With more than 5,000 procedures already completed worldwide, ZIP is safe and effective in an outpatient setting. The IRB approval allows us to launch our multicenter, prospective clinical study to investigate the efficacy of the ZIP device in managing low back pain and improving quality of life in patients suffering from a symptomatic degenerative disc. We have established a great relationship with Celéri Health for the data portion of our project using their Real World Outcomes platform," commented Trent Northcutt, Aurora’s president, CEO, and co-founder.
“The ZIP study is an important milestone for the physician community as we are committed to helping patients experiencing chronic back pain by advancing the benefits of the ZIP Screwless procedure through vigorous clinical research,” said Jason E. Pope, M.D., a pain interventionalist based in Santa Rosa, Calif.
Vipul Mangal, M.D., an interventional pain specialist from National Spine & Pain Centers, has adopted this therapy in his patients as a minimally invasive alternative approach. Dr. Mangal commented, “This device has been revolutionary in my practice as a minimally invasive device to significantly improve function and pain for my patients with back pain. I am excited to be part of the study and to train others so that we can continue to advance therapies that relieve pain and restore function.”
"This therapy is a great opportunity to continue to bridge the gap between spine surgeons and pain management for our patients,” said Steven Falowski, M.D., director of Functional Neurosurgery at Argires-Marotti Neurosurgical Associates of Lancaster, Pa. “The launch of this collaborative study will give the ability to produce published clinical outcomes utilizing a minimally invasive option to treat spinal pathology, potentially preventing a more invasive open surgical approach in the future or even give a viable treatment option to those who were not invasive surgical candidates."
“This multicenter study will involve 100 patients with results expected this year. The study is designed to demonstrate reproducible outcomes in the real-world with attention to pain, function, and quality of life. We are excited to pursue this evidence-based pathway on the ZIP implant family that has already demonstrated worldwide success. The enthusiasm from the investigators has been outstanding,” said Michael A. Fishman, M.D., MBA., director of Research at the Center for Interventional Pain & Spine in Lancaster, Pa. “Site selection has commenced, and we are appreciative of all the support from our stellar group of physicians across the country to bring this pivotal technology to market. We believe this is the future of Ultra-Minimally Invasive Spine (u-MIS) procedures.”
The IRB is a U.S. Food and Drug Administration (FDA)-registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects. Under FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
"Aurora recently conducted an advanced training session and cadaver lab that introduced leading neurosurgical, orthopedic, and pain management physicians to the ZIP implant. With more than 5,000 procedures already completed worldwide, ZIP is safe and effective in an outpatient setting. The IRB approval allows us to launch our multicenter, prospective clinical study to investigate the efficacy of the ZIP device in managing low back pain and improving quality of life in patients suffering from a symptomatic degenerative disc. We have established a great relationship with Celéri Health for the data portion of our project using their Real World Outcomes platform," commented Trent Northcutt, Aurora’s president, CEO, and co-founder.
“The ZIP study is an important milestone for the physician community as we are committed to helping patients experiencing chronic back pain by advancing the benefits of the ZIP Screwless procedure through vigorous clinical research,” said Jason E. Pope, M.D., a pain interventionalist based in Santa Rosa, Calif.
Vipul Mangal, M.D., an interventional pain specialist from National Spine & Pain Centers, has adopted this therapy in his patients as a minimally invasive alternative approach. Dr. Mangal commented, “This device has been revolutionary in my practice as a minimally invasive device to significantly improve function and pain for my patients with back pain. I am excited to be part of the study and to train others so that we can continue to advance therapies that relieve pain and restore function.”
"This therapy is a great opportunity to continue to bridge the gap between spine surgeons and pain management for our patients,” said Steven Falowski, M.D., director of Functional Neurosurgery at Argires-Marotti Neurosurgical Associates of Lancaster, Pa. “The launch of this collaborative study will give the ability to produce published clinical outcomes utilizing a minimally invasive option to treat spinal pathology, potentially preventing a more invasive open surgical approach in the future or even give a viable treatment option to those who were not invasive surgical candidates."
