LivaNova Announces CORE-VNS 24-Month Data Show Adjunctive VNS Therapy is Associated with Substantial Reductions in Generalized Tonic-Clonic Seizures in People with Drug-Resistant Epilepsy
This is the latest prospective evaluation of VNS Therapy in generalized tonic-clonic seizures
Findings include 77% median seizure reduction and 43% of participants reporting seizure freedom at 24-month visits
LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced that 24-month data on generalized tonic-clonic (GTC) seizures in people with drug-resistant epilepsy (DRE) from the CORE-VNS three-year study have been published in Epilepsia1.
Several CORE-VNS study findings were highlighted in the recent article on GTC seizures in DRE patients who received VNS Therapy™, including:
- At 12 months, the median reduction in GTC seizure frequency was 74%, and this reduction was sustained through 24 months with a median reduction increasing to 77%.
- Freedom from GTC seizures (defined as the absence of GTC seizures in the three months prior to the study visit) was reported by 37% and 43% of people at the 12- and 24-month study visits, respectively, despite people having a median 10-year duration of epilepsy.
- Approximately half of those experiencing GTC seizures were under 18 years of age, and nearly all (94%) had no history of any other previous surgery for epilepsy.
- GTC seizure reduction was seen early, with a median 52% reduction in GTC seizure frequency at the three-month study visit.
"GTC seizures can be some of the most severe and debilitating seizures a patient can experience," said Ana Suller Marti, M.D., Assistant Professor of Neurology at Western University in London, Ontario, Canada, and the lead author for this study. "The observed reductions in seizure frequency and severity, as well as the achievement of complete seizure freedom in some cases, are key findings that clinicians should be aware of."
The CORE-VNS study evaluated comprehensive outcomes of real-world evidence for more than 800 epilepsy patients treated with VNS Therapy worldwide. The 115 people with drug-resistant epilepsy and generalized seizures at baseline in this analysis had a median of 10 years between epilepsy diagnosis and VNS Therapy implantation. Additionally, 90% of this participant population were under 18 years of age at the time of diagnosis.
"I am struck by the significant seizure burden carried by the people, many of whom are so young, in this real-world dataset. Participants in this study failed a median number of six anti-seizure medications—some even as high as 20—and had a median of four tonic-clonic seizures per month at baseline," said Stephanie Bolton, LivaNova President, Global Epilepsy. "Our focus remains on contributing to the science of the treatment of epilepsy, working in partnership with physicians, and transparently communicating the latest scientific information available."
CORE-VNS participants have been followed through the 36-month study interval, and LivaNova is currently in the process of publishing 36-month study outcomes.
About CORE-VNS
CORE-VNS is a real-world, long-term, open-label study focused on the outcomes of VNS Therapy™ in people diagnosed with drug-resistant epilepsy (DRE). Enrolling more than 800 people from 61 worldwide sites, the study is the most comprehensive assessment of the effectiveness of VNS Therapy to date.
Adverse events in this published clinical trial were typical following placement of a VNS Therapy device. The most commonly reported adverse events among participants with GTCs were dysphonia, cough, neck/oropharyngeal pain, and general discomfort. See important safety information at VNSTherapy.com/safety.
About VNS Therapy™ for Epilepsy
VNS Therapy is clinically proven safe and effective as an add-on treatment to reduce the frequency of seizures in adults and children as young as 4 years old with drug-resistant epilepsy and partial onset seizures. It is a unique treatment approach developed for people with drug-resistant epilepsy—a condition that affects approximately one in three people with epilepsy. Unlike some other surgical treatment options for people with drug-resistant epilepsy, VNS Therapy implantation involves an outpatient procedure and does not require penetration of the skull. Outside the United States, the VNS Therapy indications for use may vary.
VNS Therapy has not been approved by the U.S. Food and Drug Administration (FDA) for use in primary generalized seizures, and the safety and effectiveness of VNS Therapy for the reduction of primary generalized seizures has not been established.
The VNS Therapy system is contraindicated for use in patients with a bilateral or left cervical vagotomy.
Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (hereafter referred to as diathermy) on patients implanted with a VNS Therapy System.
VNS Therapy indications for use vary by geographic location. Consult your local labeling. VNS Therapy Global Physician Manuals.
For more information, visit VNSTherapy.com.
References
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About LivaNova
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit www.livanova.com.
Safe Harbor Statement
This news release contains "forward-looking statements" concerning the Company's goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding the CORE-VNS study or VNS Therapy. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.
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