SI-BONE, Inc. Announces Publication of Postmarket Surveillance Safety Data on First 5,319 Patients Treated with iFuse Implant System
First iFuse surgeries in the UK and Canada
SAN JOSE, Calif., June 5, 2013 /PRNewswire/ — SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to fuse the sacroiliac (SI) joint, announced today the publication of the iFuse Implant System’s® postmarket surveillance safety data for the first 5,319 patients treated. The paper entitled: 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 on May 28, 2013. 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 4-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 etiology at a median 279 days post-op.(1) These rates are consistent with two previously published case series of the iFuse Implant System that reported 1-2 years post-treatment revision rates of 8% and 0%.(2,3) “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 CEO of SI-BONE.
The company also announced its continued global expansion with initial iFuse procedures being performed in Canada and the United Kingdom as well as additional surgeries in Turkey last month. Following his first six iFuse cases in Quebec City, Dr. Jean-Francois Roy, who has previously treated dozens of SI patients with open SI joint fusion said: “the patients are doing very well and I am very pleased with the initial postoperative results. 24 hours after surgery and the patients had no more pain on the operated side.” Also, Mr. Paul Rhys Davies, an orthopedic spine surgeon in Cardiff, South Wales said following completion of his first two iFuse procedures: “I have been doing SI fusions for 15 years with various techniques and I am happy with the iFuse procedure as it is reproducible, simple and straightforward. There is no need for bone graft and it is less invasive for the patient than open surgery. The fact that they can get up straight away is a big advantage to other more invasive techniques.”
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (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.
Clinical publications have identified the SI joint as a pain generator for up to 22% of low back pain patients.(4) In addition, DePalma et al, Pain Medicine 2011, identified the SI joint as a pain generator in low back pain in 43%, and may be as high as 61% of post-lumbar fusion patients, so-called “failed back surgery” patients.(5) Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option.
The iFuse Implant System is a commercially available device in the U.S. and Europe. 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. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to SI joint disorders. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of certain SI joint pathology. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2013 SI-BONE, Inc. All Rights Reserved. 8471.060413
(1)Miller LE, Reckling WC, Block JE. Analysis of the postmarket complaints database for the iFuse SI Joint Fusion System: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption. Medical Devices: Evidence and Research. 2013;6:77-84.*
(2)Rudolf L. Sacroiliac Joint Arthrodesis – MIS Technique with Titanium Implants: Report of the First 50 Patients and Outcomes. The Open Orthopaedics Journal. 2012;6:495-502.*
(3)Sachs D, Capobianco R. One year successful outcomes for novel sacroiliac joint arthrodesis system. Annals of Surgical Innovation and Research. 2012;6:13.*
(4 )Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266-80.
(5 )DePalma M, Ketchum JM, Saullo TR. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine. 2011;12:732-9.
* SI-BONE provided support for this study.
SOURCE SI-BONE, Inc.