FDA Clears SI-BONE’s iFuse Implant System® Updated Indication to Include QOL Claims

SI-BONE, Inc., has gained clearance that allows it to point to clinical studies which have demonstrated improved pain, patient function and quality of life.

Background

SI-BONE, Inc., pioneered minimally invasive surgical (MIS) fusion for certain disorders of the sacroiliac (SI) joint, culminating in its iFuse Implant System®. The newly announced, revised indication statement is based on extensive safety and effectiveness data from retrospective studies as well as three prospective clinical trials.

The iFuse Implant System has a unique patented triangular shape that provides 31 times the rotational resistance of a screw. It is the only commercially available SI joint fusion device with published clinical evidence, including three large multicenter prospective studies, that demonstrates safety and effectiveness. Currently, there are more than 40 peer reviewed publications supporting positive clinical outcomes, safety, biomechanics, and economic benefits of iFuse.

The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion, and allow for biological fixation to support long term fusion. 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.

The newly cleared indication statement allows the company to claim that clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life.

Company comments

“SI-BONE’s strong clinical evidence demonstrating consistently positive results across multiple clinical trials makes it much easier for our regulatory team and the Agency to process our regulatory applications, such as this premarket notification to update the indication statement,” said Roxanne Dubois, Vice President of Quality and Regulatory Affairs at SI-BONE, Inc. 

“This is a significant milestone in the evolution of the treatment of SI joint dysfunction and clearly sets iFuse apart from any other surgical treatment option,” said Jeffrey Dunn, President and CEO of SI-BONE. “No other surgical treatment option for SI joint dysfunction is supported by prospective data and now with over 21,000 procedures performed worldwide, iFuse is clearly the surgical treatment of choice for SI joint dysfunction due to SI joint disruption or degenerative sacroiliitis.”

Source: PR Newswire

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