SAN JOSE, California, March 2, 2015 /PRNewswire/ -- SI-BONE, Inc., a medical device company that pioneered minimally invasive surgical (MIS) fusion for certain disorders of the sacroiliac (SI) joint with the iFuse Implant System®, announced today that more than15,000 iFuse procedures have now been performed world wide utilizing more than 44,000 iFuse Implants.
Adoption of the iFuse procedure continues to grow and gain momentum with over 900 surgeons having performed the procedure in the United States and 17 countries across Europe. Several events have recently occurred that together have helped contribute to the strong iFuse procedure adoption:
- In 2014 two of the eight Medicare Administrative Contractors (MACs), Novitas and Palmetto, began covering MIS SI joint fusion procedures.
- On January 1, 2015 a third MAC, Noridian, began covering the procedure resulting in coverage for over 24 million Medicare beneficiaries in 28 states and the District of Columbia.
- On January 1, 2015 a category I CPT Code 27279 was assigned to MIS SI joint fusion.
- In 2015, seven states (MN, NY, UT, MI, IN, NE, GA) and the District of Columbia have established positive coverage for almost 6 million Medicaid patients.
"We hear success stories all the time from surgeons and their patients who've benefited from iFuse, and it is very gratifying to see the results of our efforts lead to coverage and professional society support for MIS SI joint fusion," said Jeffrey Dunn, President and CEO of SI-BONE. "15,000 surgeries is a significant milestone, but we know there are many more patients who would benefit from iFuse and we look forward to continuing our efforts to ensure that all patients who are appropriate surgical candidates have access to this life changing technology."
Clinical publications have identified the SI joint as a pain generator in 15% to 30% of low back pain patients1,2,3,4 and the prevalence of SI joint pain in post-lumbar fusion, so called "failed back surgery" patients, has been shown to be up to 43%.5 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.
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.
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.
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 patients with low back issues related to certain SI joint disorders. The company has developed, and is manufacturing and marketing, minimally invasive products for patients with certain SI joint disorders. 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. ©2015 SI-BONE, Inc. All Rights Reserved. 9090.030215
1 Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80.
2 Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
3 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.
4 Sembrano JNa, Polly DW.a How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
5 DePalma Ma, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Medicine. 2011;12:732-9.
a Investigator in a clinical research study sponsored by SI-BONE, but has no financial interest in the company.
SOURCE SI-BONE, Inc.