US-based medical device company SI-BONE has received 510(k) premarket clearance from the US Food & Drug Administration (FDA) for its iFuse Bedrock Granite implant system.
The Granite implant system is designed to provide sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion.
It was previously designated as a Breakthrough Device (BDD) by the FDA and proposed by the Centers for Medicare and Medicaid Services (CMS) as a New Technology Add-on Payment (NTAP).
In addition, CMS has approved new technology “Section X” ICD-10 unique procedure code for hospitals to report NTAP qualifying patients that use Granite as an internal fixation device with Tulip Connector for open or percutaneous sacroiliac joint fusion and sacropelvic fixation.
SI-BONE chief executive officer Laura Francis said: “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, recognising it as a new technology that can provide a 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.”
Mercy Health System innovation former vice president Scott Alexander said: “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.”
In July last year, the company announced the worldwide launch of the SI-BONE Simulator for iFuse surgeon training and education.
