Table 1.

Device regulatory approvals US & EU

	Manufacturer(s)	Approved ages	FDA approval	Year approved	CE Mark	Year approved
VNS	Cyberonics / LivaNova	≥4yrs	Focal* epilepsy	2017 (latest), 1997 (original)	Focal and generalized epilepsy	2018 (latest), 1994 (original)
DBS-ANT	Medtronic	≥18	Focal* epilepsy, ≥6 seizures / month	2018	Focal epilepsy	2010
RNS	Neuropace	≥18	Focal* epilepsy with one or two foci*, ≥3 seizures / month	2013	N/A	N/A

^*No invasive neurostimulation is FDA approved in the US for the treatment of generalized epilepsy. VNS is considered a ‘possibly effective’ treatment for focal and generalized epilepsy, and LGS, in children (2013 AAN guideline).²⁶