Shots:

• The FDA has approved Patient-Specific Talus Spacer 3D-printed talus implant for humanitarian use. The FDA reviewed data through the HDE process
• Data supporting the safety of implant include results from 31 patients and 32 talus replacement surgeries with the implant. Post-operation @3yrs- pain decreased from “mod. to sev.” prior to surgery to “mild” post-surgery- and range of motion in the ankle joint is also improved
• The implant is the first of its kind to replace the talus for the treatment of AVN of ankle joint. The implant provides a joint-sparing alternative to other surgical interventions used in late-stage AVN that may disable motion of the ankle joint

 ­ Ref:  FDA | Image: Crunchbase