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SI-BONE gets FDA clearance for iFuse-3D implant

Published 14 June 2017

SI-BONE has announced FDA clearance and full US 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 growth1

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. 

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. 

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.



Source: Company Press Release