Cerapedics was granted FDA approval for an expansion to the indications for use and labeling for PearlMatrix P-15 Peptide Enhanced Bone Graft, a Class III drug/device combination product, for adult patients with degenerative disc disease in the lumbar spine.
With this label expansion, PearlMatrix is now approved for open or minimally invasive single-level anterior lumbar interbody fusion, posterior lumbar interbody fusion, oblique lumbar interbody fusion, and lateral lumbar interbody fusion, in addition to the original approval for transforaminal lumbar interbody fusion.
Moreover, PearlMatrix is now approved for use with titanium alloy and PEEK/titanium interbody fusion cages cleared by FDA for use in the lumbosacral spine as well as the original PEEK interbody fusion cages.
“The label expansion for PearlMatrix reflects the strength of our clinical evidence. We strategically selected the TLIF approach for our ASPIRE study due to the complexity of the procedure to create a high bar of evidence before submitting our supplemental application to expand to other lumbar surgical approaches,” noted Valeska Schroeder, PhD, Chief Executive Officer of Cerapedics. “Now, even more patients have the opportunity to benefit from accelerated lumbar fusion with PearlMatrix.”
Cerapedics was granted FDA approval for an expansion to the indications for use and labeling for PearlMatrix P-15 Peptide Enhanced Bone Graft, a Class III drug/device combination product, for adult patients with degenerative disc disease in the lumbar spine.
With this label expansion, PearlMatrix is now approved for open or minimally invasive...
Cerapedics was granted FDA approval for an expansion to the indications for use and labeling for PearlMatrix P-15 Peptide Enhanced Bone Graft, a Class III drug/device combination product, for adult patients with degenerative disc disease in the lumbar spine.
With this label expansion, PearlMatrix is now approved for open or minimally invasive single-level anterior lumbar interbody fusion, posterior lumbar interbody fusion, oblique lumbar interbody fusion, and lateral lumbar interbody fusion, in addition to the original approval for transforaminal lumbar interbody fusion.
Moreover, PearlMatrix is now approved for use with titanium alloy and PEEK/titanium interbody fusion cages cleared by FDA for use in the lumbosacral spine as well as the original PEEK interbody fusion cages.
“The label expansion for PearlMatrix reflects the strength of our clinical evidence. We strategically selected the TLIF approach for our ASPIRE study due to the complexity of the procedure to create a high bar of evidence before submitting our supplemental application to expand to other lumbar surgical approaches,” noted Valeska Schroeder, PhD, Chief Executive Officer of Cerapedics. “Now, even more patients have the opportunity to benefit from accelerated lumbar fusion with PearlMatrix.”
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