SAN JOSE, Calif., Oct. 9, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (iFuse), a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that PEHP Health & Benefits of Utah, a nonprofit trust providing health benefits to Utah’s public sector employees and their families, has issued a positive coverage policy for MIS SI joint fusion with iFuse. The policy specifies positive coverage for MIS SI joint fusion using iFuse with prior authorization for CPT (current procedural terminology) code 27279 and considers open SI joint fusion with CPT 27280 experimental and investigational. In addition, the policy considers percutaneous radiofrequency ablation/denervation of the SI joint, including pulsed, non-pulsed and cooled, experimental and investigational.
“Minimally invasive SI joint fusion using the iFuse Implant has become the method of choice to treat patients who suffer from chronic pain resulting from degenerative sacroiliitis or sacroiliac joint disruption. With over 28,000 procedures performed and 54 peer-reviewed publications that include two Level 1 randomized controlled trials as well as numerous long-term studies including a 6-year study published in Neurosurgery, the iFuse Implant is the benchmark for SI joint fusion,” said Jeffrey Dunn, President, Chairman and CEO at SI-BONE. “It’s very encouraging to see health plans such as PEHP of Utah provide access to the iFuse Procedure™ for its health plan members who are suffering from chronic SI joint pain who’ve failed conservative care.”
About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs. Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.
SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes. Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.
The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions. The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution. The iFuse Implant™ was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. Patients with sacroiliac joint dysfunction experience pain that can be debilitating. SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.
The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. 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
CPT is a registered trademark of the American Medical Association. The AMA assumes no liability for data contained or not contained herein.
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. iFuse Implant and iFuse Procedure are trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 10004.100917
- Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
- Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
- 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.
- Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
- DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.
SOURCE SI-BONE, Inc.
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