Odon summit
All qualitative case study findings relating to device technique, device
design and clinical parameters for use were presented at the Odon
summit. The clinical research team presented their findings and these
were discussed, in-depth, with the manufacturers. Consensus was achieved
regarding how the device technique should be modified; however it was
agreed that the objective of confirming the IFU was not met, more data
was required to achieve this. Clinically important adaptations to device
design were agreed upon and the clinical parameters for use were
confirmed.