LivaNova won European CE Mark clearance for its SenTiva generator and accompanying Programming System for treatment of epilepsy in patients that don’t respond well to drugs. It is able to detect the onset of certain seizures and deliver extra stimulation to help to avoid or lessen the impact of the seizure. The same system received FDA approval last year.
The device measures the person’s heart rate and body position, logging the data so that it can be accessed by a physician following seizures to better understand what happened.
It comes with a programming wand and a tablet computer to wirelessly program the implant and download the data gathered within it.
Some of the features of the system, according to LivaNova:
- Guided Programming – Advanced technology allows physicians to quickly and confidently deliver a proven treatment with one touch.
- Scheduled Programming – Physicians can safely program multiple therapeutic steps in 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 target dosage sooner.
- Day-Night Programming – Physicians have unrivalled flexibility to customize therapy for when their patients need it at specific times, day or night.
Flashbacks: LivaNova’s Seizure Fighting Vagus Nerve Stimulators Approved for MRI…; LivaNova’s New SenTiva Neurostimulator for Epilepsy FDA Approved…; AspireHC Vagus Nerve Stimulator Cleared in U.S. Market…; Cyberonics AspireSR Vagus Nerve Implant Adjusts Therapy to Prevent Epileptic Seizures…