SI-BONE has announced the publication of postmarket surveillance safety data for the first 5,319 patients treated with its iFuse implant system. The report, published in Medical Devices: Evidence and Research, revealed an overall postmarket complaint rate of 3.8%, including a total revision rate of 1.8% and a late postoperative revision rate of 0.6%.
According to a company press release, the purpose of the study was to provide an analysis of postmarket surveillance complaints by evaluating SI-BONE’s postmarket complaints database. The analysis, which covers a four-year period from April 2009 to January 2013 and includes 5,319 patients, revealed an overall postmarket complaint rate of 3.8% including a total revision rate of 1.8% and a late postoperative revision rate of 0.6%.
Revisions in the late postoperative period were performed to treat symptom recurrence or for continued pain of undetermined aetiology at a median 279 days postoperation. These rates are consistent with two previously published case series of the iFuse Implant System that reported one to two years’ post-treatment revision rates of 8% and 0%.
“We are extremely proud of the safety and clinical effectiveness record that surgeons have demonstrated with the iFuse procedure. Our core focus as a company is patient safety and procedure effectiveness at an overall reduced cost to the healthcare system. We understand that additional clinical trials reporting on clinical outcomes will be published this year,” said Jeffrey Dunn, president and chief executive officer of SI-BONE.
SI-BONE received original 510(k) clearance in November 2008 from the FDA to market its iFuse implant system for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.
The iFuse procedure uses a small incision for delivery and implantation of titanium implants. The implants are coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation and long term fusion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures. The iFuse system is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.