UK medical technology company LivaNova has announced TGA approval of its SenTiva for the treatment of patients with drug-resistant epilepsy.
SenTiva is the first epilepsy device of its size designed for adults and children over four years of age living with epilepsy who are not responding to antiseizure medication.
According to International League Against Epilepsy, drug-resistant epilepsy (DRE) is defined as failure of adequate response to at least two antiseizure medications. Out of the 250,000 Australians who are diagnosed with epilepsy 35 per cent are diagnosed with DRE.
The SenTiva device is implanted in an outpatient procedure. Its features include the AutoStim Mode, also known as Seizure Response Mode, which is designed to detect changes in heart rate often associated with seizures. This may stop seizures before they start and automatically deliver an extra dose of therapy to stop seizures once started.
Uncontrolled seizures and ineffective antiseizure medication has been shown to have major psychosocial and economic impacts on patients and the Australian community.
Professor Patrick Kwan, Professor of Neurology at Monash University and consultant neurologist and director of the Epilepsy Unit at Alfred Health, said promoting awareness of DRE among neurologists is needed to help accelerate the process for patients from the initial diagnosis to referrals to epilepsy centres.
“We have seen new medicines come to market for epilepsy, but unfortunately they have not reduced the overall proportion of patients with DRE. It is important for neurologists and epilepsy centres to work collaboratively to ensure DRE patients are being assessed early for other interventions,” said Professor Kwan.
“If the patient fails to respond to two antiseizure medications that should be the trigger to refer them to epilepsy centres for further assessment. Even if we cannot immediately achieve seizure freedom, reduction in seizure frequency will still have a major impact on patients’ lives.”
VNS Therapy is an adjunctive therapy that reduces seizure frequency and severity in children and adults with DRE who are not suitable for resective surgery. It works by delivering mild pulses to the vagus nerve at regular intervals throughout the day via a small device implanted under the skin. This mechanism works to reduce seizure frequency and severity, and improve recovery time.
Professor Terence O’Brien, program director Alfred Brain and deputy director of Research, Alfred Health and President of the Epilepsy Society of Australia (ESA), welcomed the news of the new therapy option for patients with DRE.
“It can take some time for patients to receive a DRE diagnosis, and even more time for them to be referred to a comprehensive epilepsy centre. We want to see technology like VNS therapy become an important pillar in the way we manage DRE in patients who have been evaluated in a comprehensive epilepsy centre and are found to not be suitable for resective epilepsy surgery. It will help to raise better awareness of DRE, encourage earlier diagnoses and allow patients to benefit from new and advanced therapies,” said Professor O’Brien.