Cerapedics Gains FDA Approval of IDE Supplement

By Julie A. Vetalice

Cerapedics Gains FDA Approval of IDE Supplement

FDA approved Cerapedics' Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for the ongoing ASPIRE clinical trial for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF). Enrollment is reduced from 364 to 270 patients, leading to an earlier premarket approval (PMA) submission.

The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study will evaluate P-15L Bone Graft vs. autologous bone graft in TLIF.

P-15L Bone Graft is based on a small biomimetic peptide technology developed by Cerapedics to support bone growth, and is designed as a substitute for autologous bone. In 2015, the company's first-generation bone graft became the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine, following Medtronic's Infuse.

Product Labels: Bone Graft Materials/DBM

Tags: Premarket Approval, Regulatory