Sam Brusco, Associate Editor10.31.22
Aurora Spine released positive interim results from a clinical study of its ZIP MIS interspinous fusion system. Results were published in the journal Pain and Therapy, titled "A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study".
The study is evaluating using Aurora’s interspinous fusion device as therapy for treating lumbar spinal stenosis. 3-month interim analysis included 54 patients, of which 82% reported improvement as a result of the procedure, and 65% of the patients showed clinical meaningful improvement in pain and function.
Dr. Steven Falowski, a functional neurosurgeon in Lancaster, Pa. and lead investigator in this study told the press, “The 3-month clinical data in the Prospective multicenter REFINE Study is landmark in demonstrating the safety and effectiveness of a minimally invasive interspinous fusion with the Aurora ZIP implant. This opens access to more patients, who otherwise may not have had treatment options or wanted to avoid larger open spinal procedures, to receive innovative care to restore their quality of life. It is the first of its kind to collaborate with surgeons and interventional pain physicians, and also bridges the gap between conservative measures and larger open spinal procedures. I am excited to continue to follow these patients for their long-term outcomes in the study."
Trent Northcutt, president and CEO of Aurora Spine, commented, "This publication is an exciting validation of Aurora Spine’s ability to provide safe and effective outcomes by utilizing the Aurora Zip product line. We look forward to additional results published at the 12-month collection point and believe it will continue to trend positively for our physicians and their patients.”
The study is evaluating using Aurora’s interspinous fusion device as therapy for treating lumbar spinal stenosis. 3-month interim analysis included 54 patients, of which 82% reported improvement as a result of the procedure, and 65% of the patients showed clinical meaningful improvement in pain and function.
Dr. Steven Falowski, a functional neurosurgeon in Lancaster, Pa. and lead investigator in this study told the press, “The 3-month clinical data in the Prospective multicenter REFINE Study is landmark in demonstrating the safety and effectiveness of a minimally invasive interspinous fusion with the Aurora ZIP implant. This opens access to more patients, who otherwise may not have had treatment options or wanted to avoid larger open spinal procedures, to receive innovative care to restore their quality of life. It is the first of its kind to collaborate with surgeons and interventional pain physicians, and also bridges the gap between conservative measures and larger open spinal procedures. I am excited to continue to follow these patients for their long-term outcomes in the study."
Trent Northcutt, president and CEO of Aurora Spine, commented, "This publication is an exciting validation of Aurora Spine’s ability to provide safe and effective outcomes by utilizing the Aurora Zip product line. We look forward to additional results published at the 12-month collection point and believe it will continue to trend positively for our physicians and their patients.”