SI-BONE, Inc., a medical device company pioneering the use of devices for minimally invasive surgical (MIS) for the fusion of the (SI) sacriliaca, has announced the publication of data on the safety of post-marketing surveillance of iFuse Implant System's for the first 5,319 patients treated. The study titled: Analysis of the postmarket complaints database for the iFuse SI Joint Fusion System: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption, was published in Medical Devices: Evidence and Research May 28, 2013.
The study is aimed at providing an analysis of the complaints about the post-marketing surveillance through the evaluation of post-marketing database of complaints of SI-BONE. The analysis, which covers a period of four years, from April 2009 to January 2013, and includes 5,319 patients, revealed a rate of complaints overall post-marketing which includes a 3.8 per cent overall rate of revision 1, eight per cent and a revision rate of late postoperative 0.6 per cent. The revisions in the late postoperative period were performed to treat the recurrence of symptoms or persistent pain of undetermined etiology on average 279 days after the operation.
These rates are consistent with previously published case series of iFuse Implant System that signaled to one to two years after treatment revision rates from eight per cent to 0 per cent.
"We are extremely proud of the safety and clinical efficacy demonstrated by surgeons with the procedure iFuse. Our central purpose as a company is patient safety and efficacy of the procedure in a low overall cost to the healthcare system. know that other clinical study reports concerning the results will be published in this year," said Jeffrey Dunn, president and CEO of SI-BONE.
The company also announced its continued global expansion with iFuse initial procedures performed in Canada and the United Kingdom as well as other surgeries in Turkey last month. After these first six cases of iFuse in Quebec City, dr. Jean-Francois Roy, who had previously treated dozens of patients with fusion of the SI SI open said, "Patients are paying a lot of positive and are very pleased with the initial results after surgery. 24 hours after the surgery patients had no more pain in the side of the transaction." In addition, Paul Rhys Davies, an orthopaedic spine surgeon in Cardiff, South Wales said after completing his first two procedures iFuse, "I am mergers SI for 15 years with different techniques and are satisfied with the procedure iFuse because it is reproducible, simple and direct.'s not necessary to use bone grafts and is less invasive for the patient compared to open surgery. The ability to get to his feet immediately is a big advantage compared to other more invasive techniques."
SI-BONE, Inc. has received the approval of the original 510 (k) in November 2008 by the FDA (Food and Drug Administration - Authority for foods and medicines) to market its iFuse Implant System for the fixation of fractures of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint breakage and degenerative sacroiliitis, further approval in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint breakage and degenerative sacroiliitis. The CE mark for marketing in Europe was granted in November 2010.
The clinical publications have identified the SI joint as a source of pain for 22 per cent of patients with algia of the lower back. In addition, DePalma et al , Pain Medicine 2011, have identified the SI joint as a source of pain for the pains of the lower back for 43 per cent, and may reach 61 per cent in patients with post-lumbar fusion, patients defined "with the back surgery failed." The initial options for the treatment of patients with disorders of the SI typically involving the non-surgical management, and when non-surgical treatments SI joint fail in their intent, iFuse can be an alternative to surgery.
iFuse Implant System is a commercially available device in the United States and Europe. The procedure iFuse uses a small incision to make it available and the implantation of titanium implants. The implants are coated with a porous plasma spray of titanium which acts as an interference surface, designed to help reduce the movement of the system and provide an immediate fixation and a fusion of long duration. These plants have a considerable thickness and a sophisticated metallurgy and are able to provide a construct much more robust of the screws used to secure conventional surgically bone structures. iFuse System is used for the sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacrilieite. As with all surgical procedures and permanent installations, there are risks and consideration associated with the surgery and the use of iFuse Implant.