San Jose, California, February 25, 2014 / PRNewswire / -- SI-BONE, Inc. (San Jose, California), a medical device company that pioneered the use of the iFuse Implant System,® a minimally invasive surgical (MIS) device indicated for fusion of the sacroiliac (SI) joint, announced today that the Medicare Administrative Contractor (MAC) Palmetto GBA will begin covering MIS SI joint fusion, including when performed using the iFuse Implant System, effective today, on a case-by-case basis. Specifically, Palmetto has removed the CPT® code, 0334T, which is used by physicians to report the iFuse procedure, from their list of non-covered services. Palmetto is one of eight Part A/B MACs in the United States and the first to make this decision. The change will enable Medicare beneficiaries to receive coverage for the iFuse procedure throughout the states of North Carolina, South Carolina, Virginia and West Virginia. This coverage decision by Palmetto was based on published clinical data demonstrating the safety, effectiveness and clinical value of the iFuse procedure.
Clinical publications have identified the SI joint as a pain generator in up to 22% of low back pain patients.1 In addition, DePalma et al, Pain Medicine 2011, identified the SI joint as a low back pain generator in 43% to 61% of post-lumbar fusion, so-called “failed back surgery,” patients.2 Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option. The iFuse Implant System is a commercially available device in the U.S. and Europe. The iFuse procedure uses a small incision for delivery and implantation of titanium implants.
About SI-BONE, Inc. SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to SI joint disorders. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of certain SI joint pathology. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2014 SI-BONE, Inc. All Rights Reserved.
1- Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80.
2- DePalma M, Ketchum JM, Saullo TR. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine. 2011;12:732-9.
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