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

By Julie A. Vetalice

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.

P-15L graft, a substitute for autologous bone, is based on synthetic small peptide technology and was developed to spur bone growth via cell attraction, attachment and activation.

Source: Cerapedics

Product Labels: Bone Graft Materials/DBM

Tags: Regulatory, Trial/Study