Ann: Extension for Voluntary Suspension, page-173

Hi barra, It does really beggar belief at how long this has been protracted for, from what I can gather three and a half years plus.

Not sure of the time of that tragedy with the young boy but up till November 2015 (?) ‘The CardioCel devices have been sold worldwide and the manufacturer has been notified of 11 potential adverse events (including seven in Australia). Ten were reported for restenosis (at varying times, post-operatively) and one report was for thrombus formation.

’ .... the committee noted that the TGAs conclusion that the current rates of adverse events, including restenosis and thrombosis, are low compared to that seen in literature’.

Most relevant, imo, the following;

’The committee also noted the TGAs conclusion that a number of outstanding issues remain i.e the rate of adverse events in Australia is higher than seen world-wide, it is difficult to conclude if the current rates are acceptable given the cohort of patients in whom the device is used and it is not clear if the seven adverse events in Australia highlight important factors that should be included in the IFU documentation’.

For the full read access; ACSMD meeting statement, Meeting 11, 5 November 2015.

Thanks barra, just a little clarification and perhaps why this event, delay of TGA approval, had reared its head in the first place, imo.

Again really is a puzzle at why this has not been sorted out yet, despite the TGA dragging its ‘feet’!

Cheers mate.