Cerapedics receives FDA IDE approval for study of P-15L Bone Graft in TLIF surgery: 4 things to know

Written by Shayna Korol | March 14, 2018 | Print  |

Orthobiologics company Cerapedics received FDA approval to initiate a study of P-15L Peptide Enhanced Bone Graft compared to autograft in transforaminal lumbar interbody fusion surgery for degenerative disc disease.

Here are four things to know.

 

1. P-15L Bone Graft is based on Cerapedics' proprietary synthetic small peptide (P-15) technology developed to encourage bone growth through cell attraction, attachment and activation. It is designed to be used as a substitute for autologous bone.

 

2. The prospective, single-blinded, multi-center, randomized investigational device exemption clinical trial will evaluate the safety and efficacy of P-15L Bone Graft compared to autologous bone graft in TLIF surgery. The study will include 364 patients with degenerative disc disease at up to 30 clinical trial sites across the U.S. Clinical investigators may use any FDA-cleared static PEEK interbody device and any FDA-cleared pedicle fixation system delivered through either an open or minimally invasive TLIF technique.

 

3. The study's primary endpoint is composite clinical success at 24 months based on achieving radiographic fusion as assessed by CT, at least a 15-point improvement in the Oswestry Disability Index, no new or worsening persistent neurological deficit and no subsequent surgical intervention at the index level.

 

4. In November 2015, the FDA granted Cerapedics premarket approval for the use of i-FACTOR Bone Graft in anterior cervical discectomy and fusion procedures. It was the second PMA-approved bone graft in the spine. Cerapedics expects the results from the new TLIF IDE study will support a PMA application.

 

More articles on biologics:

Drs. Kevin Pauza, Gregory Lutz launch study into non-invasive degenerated disc treatment: 5 highlights

4 things to know about mensenchymal stromal cells in spine

7 things to know about Dr. Marshall R. Urist, bone morphogenetic protein pioneer

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