Latest news with #VNSTherapy
Yahoo
2 days ago
- Health
- Yahoo
LivaNova completes epilepsy treatment study of VNS Therapy
LivaNova has completed the CORE-VNS study, assessing outcomes via real-world evidence on the use of the VNS Therapy device in over 800 individuals with epilepsy. The study's final 36-month data confirms the therapy's effectiveness on severe focal seizures in paediatric and adult patients with drug-resistant epilepsy (DRE), showing early and sustained benefits. This open-label, long-term study enrolled participants from 61 sites around the world. The majority of the subjects, across all age groups, reported focal onset seizures with impaired awareness (FIA) as their most disabling seizure type. According to the study's data, for children aged four to 18, there was an 87% median reduction in FIA motor seizures at 36 months. Inclusive of adults, 34% of subjects with FIA motor seizures achieved 100% seizure minimisation, with an overall median decrease of 80%. Similarly, focal to bilateral tonic-clonic (FBTC) seizures saw a median reduction of 100% in children, and 49% of all participants with FBTC seizures reported complete seizure minimisation at their three-year study visit. VNS Therapy's effectiveness was observed as early as three months post-implantation, with further substantial decreases in both FIA and FBTC seizures observed at subsequent 12-, 24-, and 36-month visits. Notably, the CORE-VNS study claimed to have a high patient retention rate of 82% over the three-year follow-up period. LivaNova noted that VNS Therapy is an add-on treatment designed to decrease the seizure frequency in individuals aged four and above with DRE and partial-onset seizures. Involving an outpatient procedure, the implantation of this therapy does not involve skull penetration. The outcomes of the 36-month CORE-VNS study are set to be published later in the year. LivaNova Global Medical Affairs vice-president Kathryn Nichol said: 'LivaNova is deeply committed to advancing epilepsy research and in every study of VNS Therapy to date, we continue to see that effectiveness can be achieved early and continue to improve month by month and visit by visit. This remained true over the course of three years in CORE-VNS.' Last year, the company reported positive predictive outcomes from the OSPREY study of the aura6000 hypoglossal nerve stimulator system for treating obstructive sleep apnoea. "LivaNova completes epilepsy treatment study of VNS Therapy" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Business Wire
3 days ago
- Health
- Business Wire
CORE-VNS Study Further Validates Effectiveness of LivaNova's VNS Therapy on Severe Focal Seizures in Both Children and Adults with Drug-Resistant Epilepsy
LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced completion of the CORE-VNS study, evaluating comprehensive outcomes of real-world evidence for more than 800 people with epilepsy treated with VNS Therapy™ worldwide. With the clinical study report (CSR) now complete, the final 36-month data further validate the effectiveness of VNS Therapy for severe focal seizures in both children and adults with drug-resistant epilepsy (DRE) and demonstrate early and lasting outcomes of adjunctive VNS Therapy on severe focal seizures. With the clinical study report now complete, the final 36-month data further validate the effectiveness of VNS Therapy for severe focal seizures in both children and adults with drug-resistant epilepsy and demonstrate early and lasting outcomes. Share 'It is critically important to conduct long-term, real-world studies like CORE-VNS, and it is pleasing to see these clinically meaningful and durable results demonstrating the effectiveness of VNS Therapy for people living with drug-resistant epilepsy,' said Arjune Sen, Professor of Global Epilepsy at The University of Oxford and Consultant Neurologist at Oxford University Hospitals NHS Foundation Trust. Prof. Sen is also coordinating investigator for the CORE-VNS study. The CORE-VNS 36-month data analysis reaffirms the effectiveness of VNS Therapy, in pediatric and adult patients, and expands upon LivaNova's presentation of interim 24-month data evaluating the effectiveness of VNS Therapy in children ages 4 to 18 years old with focal onset seizures at the American Epilepsy Society's annual conference in December 2024. 1 Within the full 36-month analysis, the greatest proportion of patients at all ages reported focal onset seizures with impaired awareness (FIA) to be their most disabling seizure type. CORE-VNS study data demonstrate the impact of VNS Therapy, including: In children 4 to 18 years old, FIA motor seizures, for example, reduced by a median of 87% at 36 months. Including adults, 34% of people with FIA motor seizures reported 100% seizure reduction (freedom from these seizures over the three months prior to their three-year study visit), with an overall median reduction of 80%. In children 4 to 18 years old, focal to bilateral tonic-clonic (FBTC) seizures reduced by a median of 100% at 36 months. Including adults, 49% of people with FBTC seizures reported 100% seizure reduction at the three-year study visit, with an overall median reduction of 95%. The effectiveness of VNS Therapy was noted as early as three months after implantation, followed by further substantial reduction noted in both FIA and FBTC seizures at the 12-, 24-, and 36-month study visits. Unlike many long-term follow-up studies on DRE, CORE-VNS had a high patient-retention rate throughout the three years of follow-up (82%). 'LivaNova is deeply committed to advancing epilepsy research and in every study of VNS Therapy to date, we continue to see that effectiveness can be achieved early and continue to improve month by month and visit by visit. This remained true over the course of three years in CORE-VNS,' said Kathryn Nichol, Ph.D., Vice President Global Medical Affairs, LivaNova. 'Further, CORE-VNS confirms that VNS Therapy is effective for the most severe focal seizures in pediatric and adult patients. Not all seizures are created equal—this is why evaluating severe focal seizures that may have a larger impact on quality of life and outcomes in people with drug-resistant epilepsy is so important.' CORE-VNS is the largest prospective study of VNS Therapy ever conducted worldwide. The full, 36-month CORE-VNS study results will be published later this year. "The strong outcomes from the CORE-VNS study bolster our efforts to narrow the DRE treatment gap, increase access to care, and drive awareness of surgical therapies for this significantly under-addressed patient population,' said Stephanie Bolton, LivaNova President, Global Epilepsy. 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 and provides modern insights into the global use of VNS Therapy in the management and control of seizures. Adverse events in the CORE-VNS study were typical of those reported in the product labeling and experienced following placement of a VNS Therapy device. The most commonly reported (>5%) adverse events overall included respiratory, thoracic, and mediastinal disorders (dysphonia, dyspnea, cough) and general disorders/administration site conditions. See important safety information at 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. For more information, visit References 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 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 registry and VNS Therapy™ for epilepsy. 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.
Business Wire
4 days ago
- Business
- Business Wire
LivaNova Initiates Process with U.S. Centers for Medicare and Medicaid Services for Reconsideration of National Coverage for VNS Therapy for Treatment-Resistant Depression
LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it has initiated the process with the U.S. Centers for Medicare and Medicaid Services (CMS) to seek reconsideration of national Medicare coverage for VNS Therapy™ in unipolar patients with treatment-resistant depression (TRD). The first step in the process for making a National Coverage Determination (NCD) is the submission of a draft formal request for CMS reconsideration. "We have reached an important point in our pursuit to obtain national coverage for VNS Therapy for unipolar patients with depression that is difficult to treat,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. Five critical articles featuring outcomes from in-depth data analyses on primary and select secondary endpoints in the RECOVER study have recently been published in or accepted by peer-reviewed journals, and the totality of data presented in these articles serves as the basis of the Company's request to CMS. The company believes these articles satisfy the Coverage with Evidence Development (CED) requirement of sharing peer-reviewed, publicly accessible results of pre-specified outcomes measured in the RECOVER study. In addition to the five articles, the request for coverage reconsideration includes strong 24-month clinical outcomes from the unipolar cohort of the RECOVER clinical study that demonstrate the substantial retention of benefits and the durability of VNS Therapy over time. 'We have reached an important point in our pursuit to obtain national coverage for VNS Therapy for unipolar patients with depression that is difficult to treat,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. 'Our follow-on analyses of the RECOVER unipolar data demonstrate that symptoms alone may not be the sole source upon which to gauge the clinical impact of treatment. Instead, symptoms, function, and quality of life taken together present a more complete picture of treatment effectiveness. We are eager to review this powerful data with CMS during the reconsideration process.' Final Articles in Critical Series Analyze RECOVER Primary and Select Secondary Endpoint Data Two new in-depth analyses 1,2 on primary and select secondary endpoints in the RECOVER trial have recently been published and a third accepted by peer-reviewed journals. Prior to these articles, two initial articles were published in Brain Stimulation 3,4 in December 2024, completing the series of five critical articles in total. Collectively, the articles highlight the significant unmet need of this markedly ill population with TRD. The RECOVER data demonstrates that VNS Therapy improves symptoms, function, and quality of life in TRD patients over time. These are outcome measures identified as clinically relevant by CMS. Depressive symptoms, daily function, and quality of life taken together, as a novel composite metric, present a more complete picture of treatment effectiveness than symptoms alone. The fifth and final critical publication utilizes this composite metric and demonstrates favorable response to VNS Therapy in TRD patients who had previously failed multiple treatments, including interventional therapies. Researchers found that patients with previous ECT or TMS treatment had statistically significant and clinically meaningful benefits with active VNS Therapy. Notably, VNS Therapy is the only treatment that has demonstrated therapeutic effects in patients who previously failed ECT. 24-Month VNS Therapy Data Show Durability, Increasing Response Across All Outcome Measures New top-line 24-month data from the RECOVER study show that, across all outcome measures, VNS Therapy patients in the active arm of RECOVER experienced a substantial durability of benefit from month 12 to month 24. Of those patients who at 12 months had achieved clinically meaningful benefit, the median durability of benefit was 81.3% across all outcome measures at the 24-month assessment. This is considerable durability for these unipolar patients who, at baseline in the RECOVER study, had failed more than 13 antidepressant treatments on average. Observing all VNS Therapy patients in the active treatment arm of the RECOVER trial from month 12 to month 24, researchers also found improvement in all outcome measures, with the median rate of response, or clinically meaningful benefit, increasing from 40.2% at month 12 to 51.6% at month 24. 'There is no clinical evidence to demonstrate that there are any other therapies, including pharmacotherapies and interventional therapies such as electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS), that can claim this profound level of sustained durability and increasing benefit,' said A. John Rush, M.D., Professor Emeritus at Duke-National University of Singapore Medical School who has spent 25 years researching VNS Therapy for TRD and served as Chief Consultant on the RECOVER trial. 'These are critical findings that offer hope to treatment-resistant depression patients and their loved ones, who have struggled for years to find effective options. Patients not only stay better – they also continue to get better.' Improvement in suicidality shows statistically significant separation as early as month three LivaNova conducted additional in-depth analyses specifically evaluating suicidality for the active treatment arm of RECOVER through the first 12 months of therapy. Using a composite suicidality measure 5, results showed an estimated 43% higher odds of achieving meaningful improvement in suicidal ideation symptoms versus the control arm. Of specific interest, there was separation between the active and control arms on the composite suicidality metric as early as month three. Additionally, the observed separation was consistent throughout the initial 12 months. 'The composite suicidality outcome is especially encouraging because we can see a separation between the active and control arms so early in the study,' said Charles Conway, M.D., director of the Washington University Resistant Mood Disorders Center at Washington University School of Medicine in St. Louis. Conway is the RECOVER study's lead investigator. 'We're eager to further evaluate the suicidality data beyond 12 months and, in the context of the overall durability story of VNS Therapy, determine whether this benefit also continues to improve over time.' While not included in the initial submission to CMS, the suicidality data will be provided in detail to the agency upon publication in a peer-reviewed journal. RECOVER launched in 2019 as part of a CED framework per the CMS NCD process. For the unipolar cohort of RECOVER, enrollment was completed in March 2023, and the 12-month follow-up for those patients was completed in March 2024. No new safety issues were identified in the study. About RECOVER LivaNova's VNS Therapy™ System has been approved for the treatment of depression since earning CE Mark in 2001 and premarket approval (PMA) from the U.S. Food and Drug Administration in 2005. RECOVER stands for A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression. The largest randomized clinical study of its kind, RECOVER is examining up to 1,000 patients ages 18 or older who have unipolar or bipolar depression that is difficult to treat. A total of 493 adults with at least four documented unsuccessful attempts with antidepressant treatments participated in the unipolar cohort of the RECOVER study. The double-blind, randomized controlled study is assessing how VNS Therapy can offer patients relief from their depressive symptoms and improve quality of life. It is being carried out at up to 100 leading hospitals and medical centers across the United States. About VNS Therapy for Depression The VNS Therapy™ System, Symmetry™, is U.S. Food and Drug Administration-approved and indicated in the U.S. for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. The most commonly reported side effects are voice alteration or hoarseness, prickling or tingling in the skin, increased coughing, shortness of breath, and sore throat. Infection is the most common complication of the surgical procedure. Important safety information is available at References Conway CR, et al. An examination of symptoms, function, and quality of life as conjoint clinical outcome domains for treatment-resistant depression. Journal of Mood & Anxiety Disorders. April 14, 2025. DOI: 10.1016/ Sackeim HA, et al. Characterizing the effects of vagus nerve stimulation on symptom improvement in markedly treatment-resistant major depressive disorder: A RECOVER trial report. July 1, 2025. DOI: 10.1016/ Conway CR, et al. Vagus nerve stimulation in treatment-resistant depression: A one-year, randomized, sham-controlled trial. Brain Stimulation. Dec. 18, 2024. DOI: 10.1016/ Rush AJ, et al. Effects of vagus nerve stimulation on daily function and quality of life in markedly treatment-resistant major depression: Findings from a one-year, randomized, sham-controlled trial. Brain Stimulation. Dec. 18, 2024. DOI: 10.1016/ The composite suicidality metric was created by adding a suicidality-specific question from each of MADRS, Quick Inventory of Depressive Symptomology–Self Report, or QIDS-SR, and Quick Inventory of Depressive Symptomology–Clinical, or QIDS-C. 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 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 RECOVER study, the VNS Therapy™ System, Symmetry™, and the likelihood that the Company is successful in obtaining national Medicare coverage for its VNS Therapy™ System. 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.
