Theradaptive has announced that the US Food and Drug Administration (FDA) has granted breakthrough medical device designation for its OsteoAdapt SP spinal fusion implant indicated for posterolateral spinal fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis.
This marks the second breakthrough designation for Theradaptive in spinal fusion. Under the breakthrough devices programme, the FDA will provide Theradaptive with priority review and interactive communication regarding device development and clinical trial protocols during the premarket review process.
Mark Shasti of Inova Loudoun Hospital (Virginia, USA) said: “This is an important development and the potential for patients is significant. Gaining a breakthrough designation from the FDA for posterolateral fusion is a strong indication of the promise of this approach. The expansion into additional indications for spine expands access to a wider potential patient population.”
John Greenbaum, senior vice president of clinical and regulatory affairs at Theradaptive, added: “This is Theradaptive’s second breakthrough designation from the FDA in four months and expands our portfolio into the posterolateral fusion approach. This significantly increases the number of patients who can potentially benefit from this game-changing device.”