SAN JOSE, Calif., March 6, 2014 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that has pioneered the use of the iFuse Implant System®, a minimally invasive surgical (MIS) device used to fuse the sacroiliac (SI) joint, announced today that the American Medical Association's (AMA's) CPT® Editorial Panel has voted to establish a Category I CPT®Code for MIS SI joint fusion. The AMA officially announced the decision with a posting on their website (http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/cpt/cpt-summary-panel-actions.page) on Wednesday, March 5th. The new Category I CPT® code, will describe percutaneous/minimally invasive sacroiliac joint arthrodesis and will become effective on January 1, 2015.
In recent years, MIS SI joint fusion techniques have been developed and the adoption of these techniques has grown significantly. Results of a survey conducted last year by the International Society for the Advancement of Spine Surgery (ISASS) showed that over 90% of all SI joint fusions were done using MIS techniques.1 Furthermore, within the past 5 years, over 10,000 MIS procedures have been performed by more than 700 surgeons in the U.S., demonstrating substantial and widespread adoption. In addition to the prevalence of the MIS approach as compared to the open approach, a significant body of published clinical evidence now exists that demonstrates the safety and clinical effectiveness of MIS SI joint fusion for selected patients suffering from degenerative sacroiliitis or sacroiliac joint disruptions. Since the beginning of 2012 there have been 16 peer-reviewed clinical articles published on MIS SI joint fusion. Of these 16 publications, 2 are retrospective comparative cohort studies that compare open SI joint fusion to MIS SI joint fusion. Results of these studies show MIS has shorter operating time, less blood loss and fewer perioperative complications, as well as, improved long-term patient outcome measures such as disability and pain.2,3 Another study by Duhon is a prospective multicenter, single-arm trial of MIS SI joint fusion using the iFuse Implant System to treat patients with sacroiliac joint disruptions and degenerative sacroiliitis, that reports excellent safety and clinically significant improvements in pain, back function and quality of life.4 Collectively, these clinical publications demonstrate MIS SI joint fusion is safe and effective for treating patients with chronic SI joint pain due to sacroiliac joint disruptions or degenerative sacroiliitis.
"We are delighted to learn that the AMA CPT® Editorial Panel has voted to establish a Category I Code for MIS SI joint fusion and we are confident that with this new code MIS SI joint fusion will become more readily available to patients who suffer from chronic SI joint pain attributable to degenerative sacroiliitis or SI joint disruptions and who can benefit from an MIS surgical treatment option," said Jeffrey Dunn, President and CEO of SI-BONE.
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System (then called the "SI Joint Fusion System") for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.
Clinical publications have identified the SI joint as a pain generator for up to 22% of low back pain patients.5 In addition, DePalmaet 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.6 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 procedure 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. The implants are coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation and allow for biological fixation to support long-term fusion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures. The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant System.
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. 8571.112113
1 International Society for the Advancement of Spine Surgery (ISASS) Consensus Statement, July 2013.
2 Smith AG,f Capobianco R,a Cher D,a Rudolf L,b Sachs D,c Gundanna M,c Kleiner J, Milan M, Shamie AN b. Open versus Minimally Invasive Sacroiliac Joint Fusion: A Multi-Center Comparison of Perioperative Measures and Clinical Outcomes. Annals of Surgical Innovation and Research. 2013;7:14.
3 Ledonio CGT,e Polly DW Jr,e Swiontkowski MF. Minimally Invasive Versus Open Sacroiliac Joint Fusion. Clinical Orthopaedics and Related Research. 2014 Feb 12 [Epub ahead of print].
4 Duhon BS,c Cher DJ, Wine KD,a Lockstadt H,f Kovalsky D,f Soo CL.f Safety and Six-Month Effectiveness of Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study. Medical Devices: Evidence and Research. 2013;6:219-29.
5 Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80.
6 DePalma M, Ketchum JM, Saullo TR. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine.2011;12:732-9.
a Employee of SI-BONE Inc.
b Paid consultant of, conducts clinical research for, and has an ownership interest in SI-BONE, Inc.
c Paid consultant for, and conducts clinical research for, SI-BONE, Inc.
d Paid consultant for SI-BONE, Inc.
e Conducts SI-BONE-sponsored clinical research for which his institution is compensated.
f Conducts clinical research for SI-BONE.
SOURCE SI-BONE, Inc.