Cerapedics has announced that it has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its investigational P-15L bone graft for the treatment of degenerative disc disease (DDD).
The FDA’s Breakthrough Device designation is designed to expedite the development and review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary evidence must demonstrate a reasonable expectation that the device will provide improved effectiveness compared to the standard of care.
Glen Kashuba, chief executive officer of Cerapedics, said: “We are pleased the FDA has granted Breakthrough Device designation for P-15L Bone Graft, our next-generation P-15 technology platform candidate, as it underscores the urgent need for more effective treatments for patients suffering with degenerative disc disease,”
“We look forward to working closely with the FDA through the ongoing clinical trial and review processes for P-15L, with the goal of bringing this important new technology to a patient population with a significant unmet medical need.”
P-15L Bone Graft is currently being studied in the US in the ASPIRE study, a prospective, single-blinded, multi-center, randomised, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15L Bone Graft compared to use of an autologous bone graft when applied in transforaminal lumbar interbody fusion surgery. The study will include at least 270 patients with degenerative disk disease at up to 36 clinical trial sites across the US. Cerapedics say that they plan to file a Premarket Approval (PMA) submission with the FDA with the results from this study.
CAUTION: In the US, P-15L Bone Graft is an Investigational Product limited by Federal Law to investigational use only.