Aurora Spine, a designer and manufacturer of innovative medical devices, today announced plans to commence a multicenter study of its ZI Interspinous Fixation device for patients suffering from back pain due to symptomatic degenerative disc disease.

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 company is launching a multicenter, prospective clinical study to investigate the efficacy of the ZIP™ device managing low back pain and improving quality of life in patients suffering from symptomatic degenerative disc.

“The ZIP study is an important milestone for Aurora 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 Trent J. Northcutt, President and CEO of Aurora Spine, Inc.

“This multicenter study is designed to demonstrate reproducible outcomes in the real world through vigorous science and attention to quality of life. We are excited to pursue this evidence-based pathway. We continue to be very pleased with the enthusiasm of our clinical investigators,” said Northcutt. “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, minimally invasive technology to market. We believe there is a significant population of patients who will benefit from the ZIP-Screwless procedure once this important study is completed.”

“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.”
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.”

Source: Company Press Release