This study, called SIFI (Sacroiliac Joint Fusion
with iFuse Implant System) is a prospective multicenter single-arm clinical trial of SI joint fusion
using iFuse in a patient population with the same enrollment criteria as INSITE.
The iFuse System is intended for sacroiliac joint fusion
for conditions including SI joint dysfunction that is a direct result of SI joint disruptions and degenerative sacroiliitis.
Also, two additional MACs have released positive draft LCDs for MIS SI joint fusion
These latest patents make IP claims in connection with our technology that underscore our commitment to advancing the field of SI joint fusion
," said Jim Bullock, president and CEO of Zyga.
received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System (then called the "SI Joint Fusion
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.
Cartiva SCI may offer a less invasive, motion preserving solution to the traditional joint fusion
In January 2015, the Centers for Medicare and Medicaid Services (CMS) assigned a Category 1 CPT code to minimally invasive SI joint fusion
, improving patient access to the procedure.
This is the first prospective multicenter study designed to evaluate the safety and effectiveness of a minimally invasive SI joint fusion
technique in patients with degenerative sacroiliitis or SI joint disruption.
The company is marketing the SImmetry Sacroiliac Joint Fusion
System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and recently received CE Marking for the Glyder Facet Restoration Device, a non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain.
In this selected population, there is a growing body of clinical experience and published literature showing that minimally invasive SI joint fusion
is safe and effective for relieving symptoms of axial low back pain.
This approach can be an effective alternative to the traditional procedure of joint fusion
a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that the North American Spine Society (NASS) has issued their formal coverage recommendation for MIS SI joint fusion
titled "Percutaneous Sacroiliac Joint Fusion
, Defining Appropriate Coverage Positions.