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LivaNova secures CE Mark for Vagus nerve stimulation therapy system

LivaNova has secured Conformité Européene (CE) Mark for its Vagus Nerve Stimulation Therapy (VNS Therapy) System and next-generation programming system for thr treatment of epilepsy.

The US Food and Drug Administration (US FDA) approved the full system in October 2017. The system, which features the SenTiva generator and next-generation Programming System, is intended for for the treatment of patients with drug-resistant epilepsy (DRE).

The SenTiva generator offers the smallest and lightest responsive therapy with various new advanced features for the treatment of DRE

SenTiva claimed to be the only device of such a size to include the AutoStim Mode, also known as the Seizure Response Mode, which has been designed to identify seizures and can automatically deliver an extra dose of therapy.

The generator has also been designed to collect and log events such as the patient’s body position and heart rate fluctuations.

The next-generation Programming System includes a small tablet and wireless programming wand which is compatible with the SenTiva generator and all LivaNova legacy VNS Therapy generators.

When integrated with SenTiva’s technology, the Programming System can offer several options and help in delivering treatment which is both easy and efficient through a personalized patient-centric features.

Some of the features offered by the new system include guided programming, which allows physicians to quickly deliver a proven treatment with one touch.

Physicians can also program multiple therapeutic steps. The generator will then automatically increase the therapy without the need for the patient to return to the physician.

Scheduled programming can be helpful for many patients with epilepsy are not able to drive. With this feature in place, patients can achieve target dosage sooner.

Such new features help in improving patients’ overall quality of life and make VNS Therapy easy to use, while adding value to the healthcare system.

By treating with VNS Therapy, the number of seizures could be reduced, along with the average time of each seizure, coupled with faster recovery. Till date, there have been more than 100,000 patients globally.

LivaNova Neuromodulation business franchise general manager Edward Andrle said: “CE Mark combined with recent FDA approval for the SenTiva generator and Programming System advances VNS Therapy treatment for patients with drug-resistant epilepsy across the globe.”

“Not only is the new VNS Therapy System simpler to use, making drug-resistant epilepsy treatment easier, the SenTiva generator and Programming System work together to allow physicians to confidently deliver proven results through customizable, smart technology. After a successful launch in the U.S., we look forward to seeing European patients benefit from our latest technology advancements.”