LivaNova receives TGA approval for its VNS Therapy System for drug-resistant epilepsy

LivaNova

SenTiva® is the first epilepsy device of its size and weight approved for use in Australia that prevents seizures before they start and delivers extra therapy to stop seizures¹

  • VNS Therapy® is an alternative treatment option for children and adults with drug resistant epilepsy¹
  • In Australia, around 250,000 are currently diagnosed with epilepsy² with over 30% of people with epilepsy are classified as ‘drug resistant³
  • Sydney, Australia, 29 November, 2021 – LivaNova PLC (“LivaNova”), a market-leading medical technology and innovation company, has announced today the TGA registration of its vagus nerve stimulation (VNS) Therapy System, SenTiva for the treatment of patients with drug-resistant epilepsy (DRE) using VNS. SenTiva® is the first epilepsy device of its size designed to prevent seizures in people living with all types of epilepsy who are not responding to their antiepileptic medication.¹ It is available for adults and children over 4 years of age.

    According to the International League against Epilepsy, DRE is defined as failure of adequate response to at least two anti-epileptic drugs to achieve sustained seizure freedom.⁴ Out of the 250,000 Australians who are diagnosed with epilepsy more than 30%, or approximately 80,000 Australians, are diagnosed with DRE. ²,³

    VNS Therapy is an adjunctive therapy that reduces seizure frequency in children and adults with DRE who are not suitable for resective surgery.⁶ ⁷It works by delivering mild pulses to the vagus nerve at regular intervals throughout the day via a small device implanted under the skin in an effort to reduce seizure frequency and improve recovery time.⁸

    The SenTiva® device is implanted in a day (outpatient) procedure and has a feature called scheduled programming that when enabled, allows a user to schedule automated increases to output current using a protocol of up to 7 steps.8 With SenTiva, you can safely titrate multiple steps without a need for office visits.9

    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) that are often associated with seizures. This may stop seizures before they start and automatically deliver an extra dose of therapy to stop seizures once started.⁷

    Following TGA approval, SenTiva’s availability will be expanded to comprehensive 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).

    Comprehensive epilepsy centres provide comprehensive levels of support for patients who require specialised care and disease management. Due to the complex nature of DRE, early access to epilepsy specialists allows patients to receive expert education, management and care of their epilepsy, which leads to better outcomes for them.

    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 comprehensive epilepsy centres. If we know patients are not responding to antiepileptic medicines, we need to explore other options earlier. 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.

    Research has shown that uncontrolled epilepsy has major psychosocial and economic impacts on patients and the Australian community.

    The total annual cost of epilepsy in 2019-20 in Australia was estimated at $12.3 billion. This includes costs related to health care, productivity loss, informal caring, equipment, transportation and economic efficiency. Individuals living with epilepsy also often suffer from loss of quality of life due to the pain, and disruption in day-to-day activities, with a range of other health conditions including depression, anxiety and sleep disorders often being attributed to epilepsy.⁵

    Carol Ireland, Chief Executive Officer at Epilepsy Action Australia, said that despite epilepsy being one of the most common brain disorders, there is still a gap in people’s understanding of how burdensome the disease can be.

    “We receive around 4,000 referrals from people affected by epilepsy every year. This condition can be frustrating and isolating for patients, especially if the treatment is not delivering the results needed for better quality of life.

    Epilepsy is more than just seizures, it requires significant lifestyle changes and can notably limit people’s abilities to lead full and productive lives, reducing their access to educational and professional opportunities,” said Ms Ireland.

    According to Alison Ottrey, epilepsy nurse practitioner candidate at Alfred Health, raising public awareness about DRE is an important step in reducing the stigma that patients face.

    “There is still a lot of social stigma and exclusion being experienced by 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 associated with epilepsy and they are directly linked to the frequency and severity of seizures. Introducing new therapies that can prevent seizures is crucial to elevating epilepsy patients’ wellbeing,” said Ms Ottrey.

    According to Epilepsy Action Australia CEO, Ms Ireland said, “the news of a new treatment option for DRE will provide hope for many Australians and will get them a step closer to achieving better quality of life.”

    VNS Therapy is delivering benefits to over 100,000 patients globally, including over 30,000 children, due to 25 years of innovation in neuromodulation therapies.¹ In Australia, this therapy is an option for patients with DRE alongside other treatment options at comprehensive epilepsy centres.

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