Inspan Is The First Interlaminar Spinous Process Fixation Device FDA-Cleared For Spinal Stenosis and Fusion
Inspan Interlaminar Spinous Process Fixation, The First to be FDA-Cleared for Spinal Stenosis & Fusion
“Inspan is inserted through a small midline incision between two spinous processes to provide distraction/decompression and immediate stabilization.
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Inspan LLC, a KICVentures Group Portfolio Company, surprised the spine industry when in November 24th, 2021 the Food and Drug Administration (FDA) certified Inspan to be marketed with the indication for use in spinal fusion or lumbar spinal stenosis from T1-S1. Patients suffering from back pain, sciatica or neurogenic claudication due to spinal stenosis and degenerative spine disease can now be treated for these indications on-label with Inspan.
“CPT code 22867 describes open decompression or laminectomy and insertion of an interlaminar/interspinous process stabilization/distraction device without fusion including image guidance. CPT code 22612 describes arthrodesis, posterior or posterolateral technique using bone graft material.”
Inspan was first FDA-cleared in 2010 and since then has had thousands implanted by Orthopedic surgeons, Neurosurgeons and Interventional Pain Management Doctors in Hospitals and Outpatient Ambulatory Surgery Centers. Inspan has supportive biomechanical testing data and clinical studies to support its efficacy. In January 2020, Inspan presented 9 abstracts at the North American Neuromodulation Society (NANS). Below is the FDA Clearance letter for Inspan. KICVentures has given permission to DoctorprenuerNews.com to publish this letter as a public reference and to make the disclaimer that none of its portfolio companies or its employees intend to market Inspan outside the intended for use description contained within this letter.
About INSPAN, LLC
INSPAN, LLC is privately owned by the KICVentures Group and is focused on advancing the platform of patented interspinous interlaminar fixation technology. The Inspan device has a proven ten-year track record with thousands implanted since FDA clearance in 2010. There are no documented device-related failures or spinous process fractures that have plagued other competitive ISP devices.
https://myinspan.com/
About KICVentures Group
Our founders have been investing in spine surgery since 2000, which makes us the most experienced healthcare investment holding company with the largest portfolio of medical device technologies focused on solutions for less invasive outpatient spine surgery. Our investment strategy is to acquire or invent disruptive technologies using our own capital or partner with private individual investors. This allows us the freedom to make quick and nimble long-term decisions with leading physicians to advance clinical outcomes, such as when we acquired AxioMed Viscoelastic Disc Technologies, while the leading spine companies look the other way to invest in advancing spinal fusion.
https://www.kicventuresgroup.com/
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