In short
MIS Sacroiliac joint specialist SI-BONE, Inc. has issued a press release announcing that it has reached a significant milestone for its iFuse Implant System® with over 3,000 patients implanted. The device is used to minimally invasively fuse the sacroiliac joint. The company also announced that it has trained over 950 spine surgeons to date, and expects to train an additional 500-700 surgeons in U.S. and EU markets over the next twelve months.
SI-BONE claims that the increasing use of minimally invasive or mini-open fusion for SI joint conditions including degenerative sacroiliitis and SI joint disruptions is the main contributory factor to the U.S. and EU medical communities adopting iFuse as a widely accepted treatment option for treating these SI joint disorders.
Background
Clinical publications have identified the SI joint as a pain generator for up to 22 percent of low back pain patients.[1] In addition, DePalma, Pain Medicine 2011, identified the SI joint as a pain generator in low back pain in 40 to 61% of post-lumbar fusion patients, so-called ‘failed back surgery’ patients.[2]
According to SI-BONE, effective treatment of the SI joint has been identified as a significant unmet clinical need and, when non-surgical care fails, the company believes iFuse may provide an option. The company developed and patented its implant to treat the SI joint in response to increasing awareness of SI joint disruption and degenerative sacroiliitis as debilitating symptom generators.
The iFuse is a titanium implant coated with a porous plasma spray acting as an interference surface fit, to decrease implant motion. The procedure uses a minimal incision for delivery and implantation of these small, titanium implants which through a combination of substantial thickness and sophisticated metallurgy are able to produce a much stronger construct than that of conventional pins or screws used to surgically fix bony structures.
By providing initial post-operative stabilisation with fusion occurring over a number of months, the company says its system accomplishes the goal of open SI joint fusion through an MIS or mini-open approach, without compromising structural integrity of the surrounding sacroiliac bones.
Indications
The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant.
Company comments
Jeff Dunn, President and CEO of SI-BONE, commented, “We are pleased with the significant surgeon adoption of the iFuse in the U.S. and EU. To the best of our knowledge, a majority of all SI joint fusions are performed with iFuse. Surgeons using iFuse are interested in improving patient care by offering SI joint fusion and we are especially encouraged by data on 168 patients presented in six different studies over the last 18 months indicating significant improvements in pain and function scores as a result of treatment with iFuse.”
Regulatory status
SI-BONE received original FDA clearance in November 2008 to market its iFuse Implant System and an updated clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialisation was obtained in November 2010.
The iFuse Implant System is commercially available in the U.S. and EU markets.
References
[1] Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics 1987;217:266–80.
[2] DePalma, M. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine, 2011;12:732-39.
Source: SI-BONE, Inc., PR Newswire
