UK-based LivaNova has launched its new implantable pulse generator (IPG), dubbed SenTiva DUO, in the US to provide vagus nerve stimulation (VNS) therapy for drug-resistant epilepsy treatment.
The medical technology firm has designed the new implantable pulse generator with a dual-pin header that differentiates it from the original SenTiva, which comes in a single-pin format.
According to LivaNova, the latest VNS therapy technology offered by it is available to patients who were first implanted with a dual-pin lead and implantable pulse generator.
VNS Therapy patients can now change their legacy dual-pin systems with SenTiva DUO without the requirement for lead adjustment.
LivaNova said that SenTiva Duo has the same therapeutic benefits as SenTiva. Both deliver stimulation in response to rapid increases in heart rate that could be related to seizures.
Additionally, the two devices provide scheduled programming, allow day-night programming, log low heart rate events, and prone position events.
LivaNova CEO Damien McDonald said: “We’re proud to offer SenTiva DUO to serve patients who were early adopters of VNS Therapy many years ago.
“Over time, all VNS Therapy patients must replace their generators as batteries become depleted. Now, our ‘pioneer patients’ will be able to take advantage of the latest technology with SenTiva DUO and experience the full benefits of VNS Therapy, without the need to replace their dual-pin lead.”
The medical technology firm has designed its VNS therapy to treat drug-resistant epilepsy in adults and children as young as four years old who have partial onset seizures.
It is intended to be used as an adjunctive therapy to prevent seizures before they occur and stop them if they do, the company added.
SenTiva DUO is currently available in the US having received 510(k) clearance from the US Food and Drug Administration (FDA).
In November last year, LivaNova secured FDA 510(k) approval for extracorporeal membrane oxygenation (ECMO) for its LifeSPARC system, which is designed to remove the complexity associated with ECMO devices.
