SI-BONE, Inc. Announces FDA Clearance and Full U.S. Commercial Launch of the iFuse-3DTM Implant, a Patented, 3D-Printed Next Generation Member of the iFuse Implant System®
The iFuse-3D Implant combines the patented triangular shape of the iFuse ImplantTM with a proprietary 3D-printed porous trabecular surface and unique patented fenestrated design to promote bone ongrowth, ingrowth, through growth and intra-articular fusion
SAN JOSE, Calif., June 13, 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, today announced FDA clearance and full U.S. commercial launch of the iFuse-3D™ Implant (“iFuse-3D”), the first-ever 3D-printed titanium implant for use in the SI joint. SI-BONE developed a proprietary 3D-printing technology to create an implant with a unique patented fenestrated design and enhanced porous surface that resembles the trabecular structure of cancellous bone. Together, these two features provide an excellent environment for bony ongrowth, ingrowth and through growth.1
iFuse-3D leverages the clinically proven triangular titanium design of the iFuse ImplantTM that is supported by more than 50 peer-reviewed publications and has been used in over 26,000 procedures since 2009.
The iFuse-3D Implant’s surface and fenestrated structure were designed to provide enhanced osteointegration and promote intra-articular fusion. A study, published on June 1, 2017, in the International Journal of Spine Surgery (IJSS) titled: Fortifying the Bone-Implant Interface: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants1 shows significant bone growth on and into the implant’s porous surface (Figure 1) as well as through its fenestrations (Figure 2).
Scott Yerby, Chief Technology Officer at SI-BONE, commented, “the design and development of the iFuse-3D implant was a multi-year effort. Our goal was to expand the iFuse family using 3D-printing technology to provide enhanced surface characteristics while retaining key performance features of the iFuse Implant, including superior rotational resistance, mechanical strength and ease of use with our existing instrumentation. iFuse-3D, with its trabecular-like surface, provides 250% greater surface area than our highly successful iFuse Implant. Additionally, the structural fenestrations allow complete bone through growth.”
“The iFuse-3D Implant embodies our commitment to advancing the diagnosis and treatment of chronic SI joint disorders through innovative products, procedures and educational programs in order to help patients suffering from chronic SI joint pain,” said Jeffrey Dunn, President and CEO of SI-BONE. “Our team of almost 200 employees is incredibly excited to support the more than 1,300 surgeons who have used the iFuse Implant, and we believe that expanding the iFuse family has the potential to help thousands more patients. What can be more exciting and rewarding than that? “
On May 30, 2017, the U.S. Patent and Trademark Office issued patent no. 9,662,157 covering various structural design features of the iFuse-3D Implant that will extend intellectual property protection of the unique implant design for 17 years until September, 2035.
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 pain2-5, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.6 Patients with SI joint dysfunction may feel pain in the lower back, buttocks and/or legs. This can be especially true while transitioning from sitting to standing, stepping up or down, bending and lifting, walking, sleeping or even just sitting on the affected side.
SI joint dysfunction is often misdiagnosed or the pain misattributed to other causes, as not all healthcare providers evaluate the SI joint, and most patients do not ask about it. While not commonly diagnosed, SI joint disorders can be identified through a series of simple tests that include when a patient identifies their pain by pointing directly to the PSIS (the bony prominence overlying the SI joint), known as the Fortin Finger Test. The diagnosis is confirmed with physical examination and image-guided diagnostic injections directly in the SI joint.
About the iFuse Implant System
The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum. The patented triangular implant shape and patented press fit insertion technique are designed to provide immediate fixation by minimizing the SI joint’s unique motion called nutation. The implants have a porous surface that provides an environment conducive to ongrowth and ingrowth1, facilitating long-term fusion of the joint. The iFuse Implant, marketed since 2009, is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence from multiple studies that demonstrate improvement in pain, patient function and quality of life.
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
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System from the Food and Drug Administration in November 2008. The CE mark for European commercialization was obtained in November 2010.
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9848.061317
- MacBarb, et al., “Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants,” Int J Spine Surg, 2017; 11.
- 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.