General Investor Information EBR Systems, page-43

I'm not sure if you're suggesting that the WISE device will be available for general use after this SOLVE-CRT trial, but just to confirm, EBR can't/won't pursue sales of the WISE device at this stage regardless of whether it passes the Safety and Efficacy endpoints sought from this trial or not.

If the trial results meet the endpoint goals necessary then the Company will prepare a Pre-Market Approval (PMA) submission to the FDA. The Company will prepare that PMA submission through the next 6 months thereabouts, and await the FDA's determination on whether to approve the PMA.
Only after FDA approval of the PMA submission will the Company then commence commercialisation activities in the US.
Whilst WISE has been granted an approval to be used and sold within the UK and EU countries after gaining its CE Mark approval the aim is to initially commence commercialisation in the larger, and more financially attractive, market of North America, and thereafter into other selected countries.