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SI-BONE Receives Clearance from FDA to Release the iFuse-3D Implant in US

The iFuse-3D Implant by SI-BONE combines the patented triangular shape of the iFuse Implant with a proprietary 3D-printed porous trabecular surface and unique patented fenestrated design to promote bone ongrowth, ingrowth, through growth and intra-articular fusion

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.

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 Implants 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.”

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.

“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?”

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