SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System, a minimally invasive surgical (MIS) device indicated for fusion of the sacroiliac (SI) joint, announced that the US Patent and Trademark Office (USPTO) has awarded the company Patent No. 8,840,651 on systems and methods for the fixation and fusion of bone.
This newly issued patent broadly covers a threaded, fenestrated implant with a tapered distal end that may be placed from one bone across a joint into another bone. This patent further strengthens the company’s existing patent portfolio covering rectilinear shaped implants for use in the fixation or fusion of any joint in the body.
Specifically, this new patent provides coverage for “a method for the fixation or fusion of a first bone segment to a second bone segment across a joint…wherein the elongate implant comprises external screw threads wherein the elongate implant has a tapered distal end such that the first fenestration is offset from both the distal end and the proximal end…such that the first fenestration lies at least partly in the joint between the first bone segment and the second bone segment.”
“We are very pleased to learn of this latest issued patent,” said Scott Yerby, Ph.D., chief technology officer at SI-BONE. “We believe this patent addition to SI-BONE’s previously issued patents further strengthens our patent portfolio and covers certain implants intended for fixation or fusion of the SI joint, as well as other joints or fractures in the skeleton.”
This latest issued patent brings the total number of issued US patents in SI-BONE’s IP portfolio to 13 with an additional 29 pending. Outside the US, the company has one issued patent and has an additional 40 patents pending.
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.
Clinical publications have identified the SI joint as a pain generator in up to 22% of low back pain patients. In addition, the SI joint is a low back pain generator in 43% to 61% of symptomatic post-lumbar fusion, so-called “failed back surgery” patients. Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option.
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 provide immediate fixation and allow for biological fixation to support long term fusion. 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. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to SI joint disorders.