Novel device TGA approved for treatment of drug-resistant epilepsy

MedTech News: Out of the 250,000 Australians diagnosed with epilepsy, 35% or approximately 80,000 people are diagnosed with drug-resistant epilepsy (DRE).

LivaNova announced the TGA registration of its vagus nerve stimulation (VNS) Therapy System for the treatment of patients with DRE using VNS. SenTiva is the first epilepsy device of its size designed for adults and children over 4 years of age living with epilepsy who are not responding to antiseizure medication.

The SenTiva device is implanted in an outpatient procedure and features scheduled programming that when enabled, allows a user to schedule automated increases to output current using a protocol of up to 7 steps. With SenTiva, you can safely titrate multiple steps without the need for clinic visits.

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.”

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.

SenTiva offers responsive therapy with a number of new advanced features for the treatment of DRE. It includes the AutoStim Mode, also known as Seizure Response Mode, which is designed to detect changes in heart rate (ictal tachycardia) impacting a large proportions of people with epilepsy (up to 82%). This may stop seizures before they start and automatically deliver an extra dose of therapy to stop seizures once started.

Research has shown that management of drug-resistant epilepsy continues to pose challenges for both patients and healthcare professionals as the underlying mechanisms of DRE are not completely understood. Uncontrolled seizures and ineffective antiseizure medication has been shown to have major psychosocial and economic impacts on patients and the Australian community.

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.

TGA approval of SenTiva is based on the data from multiple VNS Therapy studies that demonstrated significant seizure reduction in patients with DRE:

• Up to 22% of patients experience seizure reduction of more than 90%
• With VNS Therapy, seizures are less severe and shorter, with improved patient recovery
• Majority of adult patients and at least a third of paediatric patients receiving VNS Therapy experienced significant improvements in quality of life

Following TGA approval, SenTiva’s availability will be expanded to epilepsy centres across Australia in both public and private medical facilities. This includes The Alfred (Melbourne), Royal Children’s Hospital (Melbourne), Monash Hospital (Melbourne), Westmead Hospital (Sydney), St Vincent’s Hospital (Sydney) and Queensland’s Children’s Hospital (Brisbane).

According to Alison Ottrey, Epilepsy Nurse Practitioner candidate at Alfred Health, raising healthcare professionals’ awareness about DRE is an important step in improving outcomes for patients.

“The unpredictability of epilepsy reduces patients’ quality of life and affects mental health. Depression and anxiety are some of the most common mental health co-morbidities they experience which are also directly linked to frequency and severity of seizures. Increasing healthcare professionals’ awareness and knowledge about DRE will help them confidently introduce new therapies to patients and improve epilepsy management for patients,” said Ms Ottrey.