SenTiva neurostimulator for epilepsy receives FDA approval

12th October 2017

LivaNova PLC

Enaie Azambuja

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LivaNova has won FDA approvals for its newest vagus nerve stimulation system for treating epilepsy in patients as young as four years old. The system, which includes the SenTiva implantable neurostimulator and the VNS Therapy Programming system, monitors brain activity and delivers therapy when it believes a seizure may be imminent. During therapy it continues its monitoring routine, increasing its stimulation if it detects its initial attempts failed to prevent a seizure.

The SenTiva device is now the world’s smallest available responsive stimulator for epilepsy, which makes it compatible with pretty small pediatric patients. Of course, larger patients will also benefit, as it will be more comfortable to wear compared to larger similar devices.

The implant’s settings are programmed using an app running on a computer tablet and a special wand is used to relay these wirelessly from the tablet to the SenTiva implant. The new wand and app are also backward compatible with already implanted LivaNova legacy VNS devices.

As the SenTiva device is used, it records patient data that may be clinically useful, including the heart rate and body position.

Some of the features of the new system according to LivaNova:

Guided programming – Advanced technology allows physicians to quickly and confidently deliver treatment with one touch.
Scheduled programming – Physicians can safely program multiple therapeutic steps during one office visit; the generator will then gradually and automatically increase therapy without the need for the patient to return to the physician. Scheduled programming can be very helpful, since many patients with epilepsy are not able to drive. This feature may also allow the patient to achieve a therapeutic range sooner.
Day and night programming – Physicians have unrivaled flexibility to customise therapy when their patients need it at specific times, day or night.