SI-Bone has announced that it has received US Food and Drug Administration (FDA) 510(k) premarket clearance for its iFuse Bedrock Granite implant system (Granite)—which is designed to provide sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion.
This clearance follows the earlier designation by the FDA of Granite as a breakthrough device, and most recently, a proposal by the Centers for Medicare and Medicaid Services (CMS) for a New Technology Add-on Payment (NTAP).
CMS has also issued 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 either open or percutaneous sacroiliac joint fusion and sacropelvic fixation.
Christopher Shaffrey, chief of the spine division at Duke University (Durham, USA), said: “Pedicle screws were designed for pedicles. 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.”
Scott Alexander, former vice president of innovation at Mercy Health System, commented: “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.”
Laura Francis, CEO of SI-Bone, added: “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 breakthrough device designation for its promise of providing more effective treatment than the current standard of care, and CMS’ recently proposed NTAP, recognising it as a new technology that can provide substantial clinical improvement over already available therapies.
“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.”