SI-BONE, Inc. Announces Medicare Contractor Cahaba to issue positive coverage of MIS SI Joint Fusion
"Cahaba's decision reinforces the fact that MIS SI joint fusion, for appropriately selected patients, is safe and effective and not investigational," said
"Almost 16,000 iFuse procedures have been performed and professional medical societies in
Clinical publications have identified the SI joint as a pain generator in 15% to 30% of low back pain patients.2-4 In addition, the prevalence of SI joint pain in post-lumbar fusion, so called "failed back surgery" patients, has been shown to be up to 43%.6 Of these patients, some may have degenerative sacroiliitis or SI joint disruptions. Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical management of the SI joint fails, surgical options such as the iFuse procedure may be considered.
The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion, provide immediate fixation and allow for biological fixation to support long term fusion. The iFuse System is intended for sacroiliac joint fusion for conditions including SI joint dysfunction that is a direct result of SI joint disruptions and degenerative sacroiliitis. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks
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1Whang Pa, Cher Db, et al. Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial. |
2 Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. |
3 Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7. |
4 Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92. |
5 Sembrano JNc, Polly DW.c How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32. |
6 DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Medicine. 2011;12:732-9.
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Disclosures |
a Paid consultant of, and conducts clinical research for, |
b Employee of |
c Investigators in a clinical research study sponsored by SI-BONE, but they have no financial interest in the company. |
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