SI-Bone launched a warranty program for its iFuse implant system, used in minimally invasive sacroiliac joint fusions.
Here are five things to know:
1. The warranty offers a free iFuse implant if a primary procedure using iFuse fails within one year of the initial procedure.
2. The warranty also covers revision procedures within one year of surgery that don't require a supplemental or replacement implant; the company provides a one-time credit toward an iFuse implant for use in a future procedure.
3. The iFuse implant has been used in almost 24,000 procedures and has 50 clinical publications highlighting outcomes with the technology.
4. The iFuse technology is designed to provide 31 times the rotational resistance of a screw to stabilize the joint while also including a large porous surface area for bony on-growth to support long term fusion.
5. iFuse received FDA clearance in November 2008 and has since obtained the CE mark of approval.
"Reducing revision surgeries and associated hospital readmissions is becoming increasingly important as hospitals gravitate toward 'pay for performance' reimbursement models," said Peter Whang, MD, associate professor in the department of orthopedics and rehabilitation at Yale University School of Medicine in New Haven, Conn. "The iFuse warranty program is a great example of how leading companies like SI-Bone can partner with healthcare providers to lower costs and share risks associated with patient care."