借这个公告记录一下,同样使用BMP-2的美敦力的Infuse Bone Graft在国内也获批了,虽然还没拿骨缺损修复的适应症,但我预计不会远的。不集采是有好事,有竞争也是好事。
A Study of INFUSE Bone Graft (BMP-2) in the Treatment of Tibial Pseudarthrosis in Neurofibromatosis Type 1 (NF1),University of Alabama at Birmingham,Interventional,Not Applicable
Bone morphogenetic proteins (BMPs) are important regulators of bone homeostasis and regeneration5. Infuse™ Bone Graft, containing rhBMP2 is FDA approved for spinal fusion in level 1 degenerative disk disease, open tibial fractures, alveolar ridge augmentation, and off label for bone defect healing...
先发优势是在讨论国内市场,Infuse Bone Graft在ALIF的疗效本来就能和自体骨掰手腕,活性骨哪怕证明了能在脊柱融合领域适用,疗效方面也很难有决定性优势。这要是不抓住Infuse Bone Graft刚刚获批立足未稳这几年培养好医生认知和使用习惯,趁市场空白把地圈好,等Infuse Bone Graft先行占据了脊柱市场,再去抢份额的困难度...
11. McKay WF, Peckham SM, Badura JM (2007) A comprehensive clinical review of recombinant human bone morphogenetic protein-2 (INFUSE® Bone Graft). Int Orthop 31(6):729–734. https://doi.org/10.1007/s00264-007-...
During the preparation of the outer layer, BMP2 (INFUSE® Bone Graft, Medtronic, USA) was added to the supersaturated CaP solution to a final concentration of 2 μg/ml and co-precipitated into the outermost crystalline CaP layer (BMP2-cop.BioCaP). The BMP2-cop.BioCaP particles were ...
Bone morphogenetic protein 2–Genetics Institute/Medtronic-Sofamor Danek/Integra, INFUSE Bone Graft, recombinant human bone morphogenetic protein 2–Genetics Institute/Medtronic-Sofamor Danek/Integra, RhBMP 2–Genetics Institute/Medtronic-Sofamor Danek/Integra BioDrugs 2002, 16: 376–377....
Reagents were purchased as follows: Recombinant human BMP-2 (Infuse/InductOS Bone graft kit, Medtronic, USA); BMP-2 Quantikine ELISA Kit (biotechne®, R&D systems, UK); Alcian blue 8×, Light green SF, Orange G 85% pure, Paraformaldehyde 96% extra pure, phosphomolybdic acid hydrate 80%...
F. A. D (2002) Infuse™ Bone Graft/Lt-Cage™ Lumbar Tapered Fusion device – P000058 [Online]. Available: http://www.Fda.Gov/Medicaldevices/Productsandmedicalprocedures/Deviceapprovalsandclearances/Recently-Approveddevices/Ucm083423.Htm. Accessed Aug 28 2015 Administration, U. F. A. D (...
A. Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device. J. Spinal Disord. Tech. 16, 113–122. https://doi.org/10.1097/00024720-200304000-00001 (2003). Article PubMed Google Scholar El Bialy, I., ...