SenTiva Duo received FDA 510(k) clearance. LivaNova has made it available in the U.S.
The London-based company designed its VNS Therapy as a unique approach for treating drug-resistant epilepsy. Vagus nerve stimulation (VNS) can prevent seizures before they occur and stop them if they do, the company says. The neuromodulation system offers safety and effectiveness as an add-on treatment in adults and children as young as four with partial-onset seizures.
LivaNova said the system’s dual-pin header distinguishes it from the original SenTiva, which came in a single-pin format. Those originally implanted with a dual-pin lead and IPG can receive the benefits of the company’s latest VNS Therapy technology. VNS Therapy patients can replace their device without the need for lead revision, according to a news release.
SenTiva Duo offers the same therapeutic benefits as SenTiva, LivaNova said. Both provide stimulation in response to rapid heart rate increases often associated with seizures. They also offer day-night programming, scheduled programing and they log low heart rate and prone position events.
“We’re proud to offer SenTiva DUO to serve patients who were early adopters of VNS Therapy many years ago,” said Damien McDonald, LivaNova CEO. “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.”