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Cerapedics Enrolls Patients in IDE Study of P-15L Bone Graft in TLIF -

Cerapedics enrolled the first of 364 patients in an Investigational Device Exemption (IDE) clinical trial evaluating next-gen P-15L Peptide Enhanced Bone Graft vs. autograft in transforaminal lumbar interbody fusion (TLIF). The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal study will enroll patients at up to 30 U.S. sites, with follow-up at 6 weeks, 3 months, 12 months and 24 months. Investigators can use any FDA-cleared static PEEK interbody and any FDA-cleared pedicle fixation system delivered in an open or minimally invasive technique. (Cerapedics, 7/30/18)