iFuse: FDA OKs Language Supporting Clinical Improvements

Makers of the iFuse Implant System—SI-BONE, Inc.—have announced that the FDA has cleared the iFuse Implant System to include in its indication statement that, “Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function and quality of life at 12 months post-implantation.” According to the company, this addition was based on prospective and retrospective clinical studies demonstrating consistent improvement in pain, patient function and quality of life at 12-months in patients treated with iFuse.

“We are pleased with the FDA’s review of our clinical data supporting this 510(k) clearance and look forward to additional filings as SI-BONE continues to conduct studies and follow-up on patients treated with the iFuse Implant System. Data supporting these claims came from retrospective and prospective studies, including INSITE (Investigation of Sacroiliac Fusion Treatment; 148 patients), SIFI (Sacroiliac Joint Fusion with iFuse Implant System; 172 patients) and additional studies reviewed by the Agency, ” said Roxanne Dubois, Vice President of Quality and Regulatory Affairs at SI-BONE, Inc., in the November 9, 2015 news release.

“Over 20 clinical studies demonstrating safety and effectiveness with the iFuse Implant System have been published in peer reviewed journals including studies with follow up out to as much as five years. Over 18, 000 iFuse procedures have been performed worldwide making it the leading minimally invasive solution for these patients, ” commented Jeff Dunn, President and CEO of SI-BONE, Inc.

Asked how they plan to grow the company, Dunn told OTW, “We’re focused on moving our business forward quickly with the right partnerships and right financing. As always, we’re continuing our deep commitment to evidence and education. The diagnosis of SI joint dysfunction is as equally, if not more, important than the treatment. In anticipation of increased global demand for the procedure and the evolving reimbursement conversation, educating physicians at all levels of the care continuum continues to be key.”

As for the next 6-12 months, he added, “iFuse is now the only MIS SI joint fusion device whose FDA clearance includes improved pain, patient function and quality of life at 12 months post-implantation. This is a significant competitive differentiator, which we expect will further contribute to our long-term market leadership. And, it’s a reflection of our ongoing commitment to rigorous clinical studies—without the supporting safety and effectiveness evidence, this milestone would not have been possible. Over 18, 000 iFuse procedures have been performed to date, and we anticipate our expanded application approval will further drive procedural growth and revenue.”