相关临床试验
3
2 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
1
33.3%
已完成
1
33.3%
尚未招募
1
33.3%
暂无批准数据
- Cerapedics received FDA approval to expand PearlMatrix P-15 Peptide Enhanced Bone Graft indications to include all major lumbar interbody fusion approaches, making it the only Class III drug-device spinal bone graft approved for comprehensive lumbar procedures. - The expansion follows the ASPIRE pivotal study published in Spine, which demonstrated statistically superior fusion speed and composite clinical success compared to local autograft in transforaminal lumbar interbody fusion procedures. - PearlMatrix is now approved for use with titanium alloy and PEEK/titanium interbody fusion cages in addition to original PEEK cages, addressing the lumbar fusion market that represents approximately two-thirds of all fusion procedures. - The approval came within three months of submitting the supplemental application, reflecting the strength of clinical evidence from the rigorous ASPIRE trial that included high-risk patient populations.
- Cerapedics received FDA premarket approval for PearlMatrix P-15 Peptide Enhanced Bone Graft, the first proven bone growth accelerator for lumbar fusion procedures. - The ASPIRE pivotal trial demonstrated statistically superior fusion speed with over twice as many patients achieving fusion at six months compared to local autograft. - The approval addresses a critical unmet need in spinal fusion surgery, where bone fusion can take up to 12 months to complete. - PearlMatrix received FDA Breakthrough Device designation and represents one of only three spinal bone grafts with PMA approval among over 350 available products.
