Main Category: Arthritis / Rheumatology
Also Included In: Regulatory Affairs / Drug Approvals; Medical Devices / Diagnostics
Article Date: 28 Apr 2011 – 0:00 PDT
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SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint announced the U.S. Food and Drug Administration (FDA) approved a major modification to the existing product label. The Approval targets the use of iFuse Implant System® for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
In the spirit of collaboration, FDA-OSDB worked with SI-BONE, Inc. to arrive at a more accurate description of the intended use of the iFuse System. The communications were helpful in differentiating the iFuse System from fracture fixation devices. Based upon internal discussions, as well as a review of the medical literature related to SI joint disease and associated clinical care, FDA agreed to remove “fracture” from the indications for use and to further modify the indications for use statement as follows: “The SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, as the Agency believed this is more in line with the true intent of SI Joint Fusion System.”
Commenting on the FDA approval of SI-BONE’s 510(K), CEO, Jeff Dunn said, “This approval from the Agency provides us with a significant advantage in getting the word out on appropriate diagnosis of low back complaints that include the SI joint and that an MIS option for patients with SI joint problems and provides us with a unique opportunity to teach spine surgeons about the iFuse Implant System for SI joint fixation/fusion.”
Barbara Bunger, Vice President, Clinical, Regulatory and Quality at SI-BONE stated, “It’s important for companies, like SI-BONE, Inc., to work closely with the FDA in developing solutions for patients with low back complaints due to the SI joint and the company looks forward to further collaborations and discussions with the Agency as the clinical development plan progresses. Our working relationship will ensure the design of a pivotal study that will provide clinical data to support low back pain claims.”
SI-BONE received clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010. The iFuse provides immediate post-operative fixation, accomplishing the goal of traditional open SI joint fusion through an MIS approach. Clinical publications have identified the SI joint as a pain generator for up to 22% of low back pain patients and that up to 75% of post-lumbar fusion patients develop SI joint degeneration within 5 years of surgery. These represent significant unmet clinical needs where iFuse may provide an MIS option.
In response to increasing awareness of SI joint disruption and dysfunction as debilitating symptom generators, SI-BONE, Inc. developed an innovative, patented, intramedullary implant to treat the SI joint. The company is also embarking on a post-market multicenter study to determine its effect over time on SI joint pathology and on symptoms associated with SI joint problems.
Source: SI-BONE, Inc
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