Augment Pitch Flashcards
Hey dr galley - first intro
Hey Dr. Kim.. I noticed you had a patient over 65 for your Ankle Fusion case today, are you planning on using any bone graft?
Dr galley- Yes I was planning on using a bone graft.
Have you heard of Augment? It’s a bioengineered human platelet derived growth factor. It is the only biologic product specifically engineered for ankle and hindfoot fusions. It is the one and only FDA approved level 1 alternative to autograft and has been proven to have 2x the success rate in patients over the age of 65.
Dr galley: how does it have 2x the success rate?
It’s technically an allograft but it is a synthetic bioengineered human platelet derived growth factor so its highly purified 100% of the time. So when injecting it into that fusion site its incredibly successful in healing and bone repair without those morbidities or risks that you could get with autograft in an older patient.
If you are free for lunch today i’d love to show you more of the literature on it to show how much of a game changer this product is.
Osteoconductive
Bone grows on a surface
Hoe does augment work
AUGMENT® Bone Graft is a bioengineered and proven alternative to autograft in ankle and hindfoot fusions.
The product consists of two primary components: » β-TCP granules (1000-2000 μm)
» rhPDGF-BB solution (0.3 mg/mL)
At the point of use, the two components are mixed and applied to the surgical site. The β-TCP component provides a porous scaffold to support cell attachment and delivery of the rhPDGF-BB molecule
Evidence / why is it important (science)
The role of PDGF in bone repair and regeneration is documented in at least ten peer-reviewed publications including two large-scale randomized, controlled clinical trials involving rhPDGF-BB/β-TCP.
This Level-I clinical data is considered the most reliable quality of data based upon standards for peer-reviewed evidence.
How was it approved
AUGMENT® BoneGraft was approved via the rigorous PMA pathway by the U.S. FDA as a Class III combination medical device/drug product.
The PMA application was supported by two pilot clinical trials, the largest prospective, randomized controlled clinical trial in foot and ankle history.
Proven level 1 ….
Proven - Level 1 evidence of safety and effectiveness as a replacement to autograft in the largest F&A clinical trial ever conducted as well as having over 20 peer reviewed publications.
