SI-BONE Announces iFuse Implant System Warranty Program

SI-BONE Inc., a 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 low^1-3, 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 here.
 
“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-growth⁴ 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.”
 
References
¹Polly 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.
²Duhon 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.
³Cher 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.
⁴Data on file: TR 300401-A and 300359-A