The Resorbable Orthopaedic Products subsidiary (ROP) of Wound Management Technologies has received FDA 510 (k) clearance for its product HemaQuell Resorbable Bone Wax.
Resorbable Bone Wax Receives FDA Clearance
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HemaQuell is a water soluble material that is used as a tamponade to control bleeding from bone surfaces. It will be delivered in an applicator that will allow surgeons to apply the waxy product directly on bleeding bones. HemaQuell bone homeostasis material is completely reabsorbed between two and seven days and does not delay the healing of bone injuries, according to a company report.
“This product will be valuable to control bleeding in bones during surgery, ” said Blaine Farless, M.D., Medical Director of Resorbable Orthopedic Products. “I look forward to working with our surgical group on the market launch and introduction of this revolutionary product.”
“We are extremely pleased to have this approval for HemaQuell, ” commented Deborah Hutchinson, President of Wound Management Technologies. “This project was headed by Barry Constantine, our Director of Research and Development and co-inventor of the related patent. Our surgical sales team has been looking forward to the introduction of this product and we have several surgeons lined up to begin evaluation cases.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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