SI-BONE, Inc. Announces FDA Clearance and Full U.S. Commercial Launch of the iFuse-3D™ Implant, a Patented, 3D-Printed Next Generation Member of the iFuse Implant System®

I-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. 

iFuse-3D leverages the clinically proven triangular titanium design of the iFuse Implant™ 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.