SI-BONE partners with customers to provide further assurance of product safety and effectiveness as demonstrated in almost 50 peer-reviewed published papers
SAN JOSE, Calif., Jan. 9, 2017 /PRNewswire/ -- SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® ("iFuse"), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced a revolutionary iFuse warranty program. The new warranty goes beyond guaranteeing the integrity of the product by focusing on actual procedure-related outcomes and positive patient results. Although revisions of SI joint fusion procedures with iFuse have been shown to be low1-3, this new warranty will provide users with a free iFuse Implant™ to either supplement or replace previously placed iFuse Implants within a one-year period following the initial or index procedure, should a revision be required. In addition, for any revision procedure that occurs within the one-year warranty period that does not require a supplemental or replacement iFuse Implant, the warranty provides a one-time credit towards an iFuse Implant for use in a future iFuse Procedure™. Terms and conditions of the new warranty are available at https://si-bone.com/warranty/
"This is a ground-breaking warranty within our industry, which is based on the integrity of our product and focused on actual patient outcomes," said Jeffrey Dunn, President and CEO of SI-BONE. "Our warranty illustrates the confidence we have in our product and procedure based on the almost 50 positive iFuse clinical publications, extensive practical experience of nearly 24,000 iFuse surgeries and our industry-leading medical education and field teams. When I meet with providers, there is a common interest expressed in that hospitals and payors don't want to pay for competitive products when they have no idea what the results, revision rates or durability will be. Our warranty further demonstrates our uncompromising commitment to these health care providers and their patients."
The iFuse Implant offers a unique advantage for stabilizing and fusing the SI joint as a result of its patented triangular shape and large porous surface area. The triangular shape provides more than 31 times the rotational resistance of a screw which stabilizes the joint while the large porous surface area provides an ideal environment for bony on-growth* to support long-term fusion.
"Reducing revision surgeries and associated hospital readmissions is becoming increasingly important as hospitals gravitate toward 'pay for performance' reimbursement models," said Peter Whang, MD, FACS and Associate Professor in the Department of Orthopaedics and Rehabilitation at the Yale University School of Medicine. "The iFuse warranty program is a great example of how leading companies like SI-BONE can partner with health care providers to lower costs and share risks associated with patient care."
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System ("iFuse") from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.
The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum. The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion. The implants have a porous surface that provide an ideal environment for bone on-growth and ingrowth, facilitating long-term fusion of the joint*. iFuse is the only commercially available SI joint fusion system in the United States with published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials. Currently, there are more than 45 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results). It is the only SI joint fusion system with a FDA clearance recognizing demonstrated improvements in pain, patient function and quality of life following treatment.
The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9756.010917
*Data on file: TR 300401-A and 300359-A
1. Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10:Article 28. doi: 10.14444/3028.
2. Duhon B, Bitan F, Lockstadt H, Kovalsky D, Cher D, Hillen T, on behalf of the SIFI Study Group. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial. Int J Spine Surg. 2016;10:Article 13. doi: 10.14444/3013.
3. Cher DJ, Reckling WC, Capobianco RA. Implant Survivorship Analysis after Minimally Invasive Sacroiliac Joint Fusion using the iFuse Implant System. Med Devices (Auckl). 2015;8:485-92. doi: 10.2147/MDER.S94885.
One or more of the individuals named herein may be a past or present SI-BONE employee, paid consultant, investor, clinical trial investigator, or grant recipient. Research described herein was supported by SI-BONE.
Published at PRNewsWire