SI-BONE Gains Expanded Indication for the iFuse-TORQ Implant

By Julie A. Vetalice

SI-BONE Gains Expanded Indication for the iFuse-TORQ Implant

SI-BONE received FDA clearance to market iFuse-TORQ® for pelvic fracture fixation, including acute, non-acute and non-traumatic fractures. Fractures covered in this clearance include pelvic fragility fractures (those related to low-energy traumatic events) and pelvic insufficiency fractures.

Sacral fragility and insufficiency fractures are common and often devastating for patients and healthcare systems, where:

  • 120,000 sacral fragility or insufficiency fractures occur annually in the U.S.
  • 78% of patients are treated with bed rest, leading to 14- to 45-day hospital stays
  • 27% 1-year mortality results from bed rest-associated complications

“Since its launch in 2021, iFuse-TORQ has been used to treat many patients suffering from a pelvic fracture or sacroiliac joint dysfunction,” said Laura Francis, CEO of SI-BONE. “This pelvic fracture fixation indication expansion comes on the coattails of the iFuse Bedrock Granite launch and expands SI-BONE’s position as the market leader in the sacropelvic space.”

Source: SI-BONE, Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory