LivaNova PLC today announced it received CE Mark for its Vagus Nerve Stimulation Therapy® System comprised of the SenTiva® generator and next-generation Programming System for the treatment of patients with drug-resistant epilepsy. The Company received FDA approval for the full VNS Therapy System in October 2017.
The SenTiva generator offers the smallest and lightest responsive therapy with a number of new advanced features for the treatment of DRE. SenTiva is the only device of its size to include the AutoStim Mode, also known as Seizure Response Mode, which is designed to detect seizures and automatically deliver an extra dose of therapy. The generator is also designed to collect and log events including a patient’s body position and heart rate fluctuations.
The next-generation Programming System includes a small tablet and wireless programming wand compatible with the SenTiva generator and all LivaNova legacy VNS Therapy generators. When combined with SenTiva’s smart technology, the Programming System provides several advanced options and makes delivering treatment easier and more efficient through personalized patient-centric features.
Edward Andrle, LivaNova’s General Manager of its Neuromodulation business franchise. reports, “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.” Ease of the System, Andrle notes, “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.”
New System’s features:
- 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.
The new features will help improve patients’ overall quality of life, make VNS Therapy easier to use and bring value to the healthcare system. Treatment with VNS Therapy can result in fewer seizures, shorter seizures and faster recovery; to date, it has been used by more than 100,000 patients globally.1
“SenTiva provides exciting advances in neuromodulation therapy for drug-resistant epilepsy. The smaller size and new programming features expand the range of patients we can treat,” said Dr. David McCormick, Clinical Lead for Paediatric Neurosciences at King’s College Hospital, London. “To that end, we are pleased to announce that the first SenTiva implant in a pediatric patient in Europe took place at King’s College Hospital in London.”
1. Data on file, LivaNova PLC, Houston, TX.
About VNS Therapy for Epilepsy
VNS Therapy is clinically proven safe and effective for the treatment of drug-resistant epilepsy for adults and children. VNS Therapy is designed to prevent seizures before they occur and stop them if they do. It is a unique treatment approach developed for people with drug-resistant epilepsy—a condition that affects one in three people with epilepsy. For more information, visit www.VNSTherapy.co.uk
INTENDED USE/INDICATIONS – EU
The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to seizure medications.
Individual results may vary. Common side effects include hoarseness or changes in voice tone, prickling feeling in the skin, shortness of breath, sore throat and coughing. Visit http://en.eu.livanova.cyberonics.com/safety-information to view safety and full prescribing information.