First 3D Implant for SI Joint Cleared by FDA
Walter Eisner • Mon, June 19th, 2017
SI-BONE, Inc. has received FDA clearance and a patent for its iFuse-3D implant.
In a June 13, 2017 announcement, the company said the implant provides 250% greater porous surface area than its original iFuse implant and uses a patented fenestrated design and enhanced porous surface that resembles the trabecular structure of cancellous bone.
To receive FDA clearance, a company must show how the device is similar to a previously approved "predicate" device. In this case, the company's predicate for the 3D implant, was its own previously cleared non-3D iFuse device. The company first received FDA 510(k) clearance to market its iFuse Implant System in November 2008. The CE mark for European commercialization was obtained in November 2010.
That implant, designed to mimic native cancellous bone and use self-harvesting technology, is supported by more than 50 peer-reviewed publications and has been used in over 26,000 procedures since 2009.
This, according to the company, is the first-ever 3D-printed titanium implant for use in the SI (sacroiliac) joint. The 3D technology developed for this device is proprietary for the company. 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.
To bolster their claims, the company points to 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,” which shows "significant bone growth on and into the implant's porous surface as well as through its fenestrations."
Scott Yerby, company's chief technology officer, said 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. Additionally, the structural fenestrations allow complete bone through growth."
The iFuse Implant System
According to the company, the 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 ingrowth, facilitating long-term fusion of the joint," states the company. The implant, marketed since 2009, is the only commercially available SI joint fusion device in the U.S. with published prospective clinical evidence from multiple studies that demonstrate improvement in pain, patient function and quality of life.
Company President Jeffrey Dunn the said his team of almost 200 employees is incredibly excited to support the more than 1,300 surgeons who have used the 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?"
Click here to watch a video of the implant in use.