SI-BONE’s New iFuse-NavigationTM Set* and iFuse-3DTM Fenestrated SI Joint Fusion Implant to be Featured at the 2017 North American Spine Society Annual Meeting
SAN JOSE, Calif., October 23, 2017 -- 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 its new iFuse-Navigation Set* and proprietary 3D printed iFuse-3D fenestrated triangular titanium implant, will be featured at this year’s North American Spine Society (NASS) annual meeting in Orlando, FL. The new iFuse-Navigation Set was designed to allow surgeons using the O-armTM imaging system and StealthStationTM navigation system to perform the iFuse procedure for MIS SI joint fusion.
In addition to the new iFuse-Navigation Set, the company will also showcase its new iFuse-3D Implant. This novel implant combines the patented triangular shape of the iFuse ImplantTM with a proprietary 3D-printed porous trabecular surface and unique patented fenestrated design which is intended to enhance bony ongrowth, ingrowth, through growth and intra-articular fusion.
The company will also be hosting Dr. David Polly**, Chief of Spine Surgery at the University of Minnesota, on Thursday, October 26th from 3:10 pm to 3:40 pm at its booth (#1518) in the NASS exhibit hall. Dr. Polly will present and discuss his experience utilizing navigation with the iFuse Procedure as well as his clinical experience with the new iFuse-3D Implant.
“We are excited to have Dr. Polly join us at our booth and we’re grateful that he has offered to take time to share his clinical experience with the iFuse Implant System® and navigation as well as provide his initial perspective on the new iFuse-3D Implant,” said Tony Recupero, Chief Commercial Officer at SI-BONE. “We have made great progress this past year toward advancing the diagnosis and treatment of SI joint disorders and we look forward to this year’s NASS meeting to help build on that progress and create even greater awareness about the condition and access to our procedure.”
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 ImplantTM 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
*Pending 510(k), not available for sale in USA.
**Dr. Polly was an investigator on a clinical research study sponsored by SI-BONE. He has no financial interest in SI-BONE.
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. iFuse-Navigation and iFuse-3D are trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. All other trademarks are property of their respective owners.
- 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.