BOSTON (PRWEB) FEBRUARY 11, 2020
INSPAN LLC (a privately-owned company) is pleased to announce the successful results from a long-term follow-up clinical study of outpatient L4-L5 lumbar interspinous fixation for degenerative spinal stenosis using the Inspan interspinous fixation device (INSPAN LLC). Unlike extension block design, the Inspan device fixates the spine to allow for immediate stability, distraction, decompression, and fusion. Based on biomechanical studies, the Inspan device may be the strongest interspinous fixation device on the market and thus is being used for spinal fusion replacing the traditional method that uses pedicle screws and interbodies with laminectomies.
The study was performed at the LESS Institute by Professor Dr. Kingsley R Chin, MD, a board-certified orthopedic spine surgeon and coauthors Dr. Fabio Pencle and Dr. Jason Seale.
The study was a retrospective review of prospectively collected data under an IRB approved study cohort. The study evaluated 122 surgical cases of lumbar decompression with interspinous fixation from September 2011 to October 2016. A total of 56 patients had instrumentation at L4-L5. Total female population was 46%. The median age of the patients included in the population was 50.9+/-10.7 years with a median BMI of 24.8+/-11.4 kg/m2. Two-year VAS and ODI showed significant improvement form 8.1+/-1.2 to 1.5+/-1.1 and 42.9+/-14.3 to 14.8+/-5.1. All surgeries were completed in less than one hour. There was a total of one revision case with removal of Inspan and converted to an open hemilaminectomy decompression.
In conclusion, the long-term outcome of the study demonstrated improved outcomes in patients who underwent interspinous distraction decompression in an ambulatory surgery center using the Inspan device at L4-L5 for degenerative spinal stenosis. There were no complications or implant failures.
About INSPAN, LLC
INSPAN, LLC is privately owned by KICVentures and is focused on advancing the platform of patented interspinous fixation technology. The Inspan device has a proven ten-year track record with thousands implanted since FDA-clearance in 2010.
Inspan FDA Indications
The Inspan Slim Spinous Process Plate System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture ordislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies). The device is intended for use with bone graft material and is not intended for stand-alone use.