Jun 13, 2017 | By Tess

SI-BONE, Inc., a medical device company based in San Jose, California, has received FDA clearance for its iFuse-3D implant, the first titanium 3D printed implant for the sacroiliac (SI) joint. The company also announced the commercial launch of the 3D printed implant across the United States.

SI-BONE is perhaps best known as the developer of the iFuse Implant System, which consists of a triangle-shaped minimally invasive surgical (MIS) device specifically designed for the treatment of SI joint disorders. The SI joint, located between the sacrum and the ilium bones of the pelvis, has been recognized as the cause of chronic lower back pain for 15 to 30% of patients who suffer from it.

With the FDA approval for its iFuse-3D implant, SI-BONE is launching its very first 3D printed implant for SI joint fusion. According to the company, the implant was realized using a proprietary 3D printing process, which has allowed it to produce a “unique patented fenestrated design and enhanced porous surface” that mimics the trabecular structures of cancellous bone.

Largely due to the implant’s unique 3D printed titanium structure, SI-BONE’s iFuse-3D implant provides the right conditions for encouraging bone ongrowth, ingrowth, and through growth. The 3D printed implant is based on the original iFuse Implant, which has been recognized by various relevant publications and has been used in over 26,000 procedures since the year 2009.

"The design and development of the iFuse-3D implant was a multi-year effort,” said Scott Yerby, Chief Technology Officer at SI-BONE. “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 was officially granted a patent on May 30 by the U.S. Patent and Trademark Office. According to the patent, the 3D printed implant, including its structural design features, are protected for 17 years, until September 2035.

A recently published study, entitled “Fortifying the Bone-Implant Interface: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants,” details the significant bone growth that occurred with the iFuse-3D implant’s fenestrated structure.

"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," commented Jeffrey Dunn, President and CEO of SI-BONE.

SI-BONE’s iFuse-3D implant is the latest 3D printed implant to be approved by the FDA. The approval marks a significant step towards further integration of 3D printing technologies in the medical device and implant field.



Posted in 3D Printing Application



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