Submitted by kBLASTER Team on
by Fink Densford for Massdevice.com
Si-Bone said today it won FDA 510(k) clearance for its minimally invasive iFuse implant system designed for fusion of the sacroiliac joint.
The device is cleared for treating certain disorders of the sacroiliac joint, and its indication includes a statement that treatments with the device “improved pain, patient function and quality of life at 12-months post implantation,” San Jose, Calif.-based Si-Bone said.
“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,”quality and regulatory affairs veep Roxanne Dubois said in a press release.
The expanded application approval was cleared based on prospective and retrospective clinical studies of the device at 12-months, Si-Bone said.
“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 5 years. Over 18,000 iFuse procedures have been performed worldwide making it the leading minimally invasive solution for these patients,” CEO Jeff Dunn said in prepared remarks.
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