SI-BONE’s iFuse Bedrock Granite Implant Earns FDA Nod

SI-BONE has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its iFuse Bedrock Granite implant system for sacroiliac fusion and sacropelvic fixation as a foundation for segmental spinal fusion.
 
Granite was previously awarded FDA breakthrough designation and recently granted a proposal by the Centers for Medicare and Medicaid Services (CMS) for a New Technology Add-on Payment (NTAP).
 
CMS also gave new technology “Section X” ICD-10 unique procedure coding for hospitals to report NTAP eligible cases that use Granite as an internal fixation device with tulip connector for open or percutaneous sacroiliac joint fusion and sacropelvic fixation.
 
“Pedicle screws were designed for pedicles,” Christopher Shaffrey, MD, Chief of the Spine Division at Duke University told the press. “When spine surgeons began anchoring screws into the pelvis to strengthen the base of the spinal constructs, surgeons simply used longer and larger diameter pedicle screws in iliac and sacro-alar iliac trajectories. Numerous clinical studies have shown significant issues with this strategy; screw loosening, post-operative sacroiliac joint pain and hardware failure. With Granite, there is now a device designed for the specific demands of the sacropelvic anatomy. I am very excited for the many patients who will benefit from this new technology.”
 
“Reoperations following adult spinal deformity surgery occur in over 20% of all cases. That’s an expensive problem from a time, cost, and patient discomfort standpoint. It is refreshing to see that CMS recently proposed an NTAP for SI-BONE’s iFuse Bedrock Granite. The adoption of that product should lead to fewer reoperations, better patient outcomes, and less cost to the system,” said Scott Alexander, Former Vice-President of Innovation at Mercy Health System.
 
“We are thrilled to receive FDA 510(k) clearance to launch Granite to the market. The anticipation has been building ever since the FDA awarded BDD for its promise of providing more effective treatment than the current standard of care, and CMS’ recently proposed NTAP, recognizing it as a new technology that can provide substantial clinical improvement over already available therapies,” said Laura Francis, CEO of SI-BONE. “Based on the early pre-clinical data from in vivo animal studies suggesting significant bone ingrowth and superior mechanical stability, internal studies showing markedly improved biomechanics, and initial feedback from surgeons, we couldn’t be more enthusiastic about Granite’s clinical and commercial promise as a uniquely disruptive technology.”