Latest news with #AhmetTezel
Business Wire
6 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.
Business Wire
07-05-2025
- Health
- Business Wire
LivaNova Announces 12-month Data from OSPREY Clinical Study for Moderate to Severe Obstructive Sleep Apnea, Demonstrating Strong Response and Durability of Therapy
LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced 12-month, top-line data from its OSPREY randomized controlled trial (RCT), evaluating outcomes with the aura6000™ System for the treatment of moderate to severe obstructive sleep apnea (OSA). At 12 months of therapy, the treatment arm responder rate was 65% with responders defined as those who realized at least a 50% improvement from the baseline apnea-hypopnea index (AHI) and an AHI value below 20. The study features a differentiated neurostimulation modality called proximal hypoglossal nerve stimulation (p-HGNS), which utilizes six electrodes placed on the proximal trunk of the hypoglossal nerve, offering broad access to the muscles controlling the airway and providing customized titration. 'The OSPREY trial demonstrated rapid and sustained improvement for patients who received active proximal hypoglossal nerve stimulation,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. In , the company announced that OSPREY met its primary and secondary endpoints following six months of therapy. Study patients in the treatment arm of OSPREY have since shown continued improvement. When comparing baseline median values to six and 12 months of therapy (assessed at the seven- and 13-month follow-up visits, respectively), OSPREY subjects showed significant reductions in AHI and oxygen desaturation index (ODI) over time: AHI reduced by 68% when the median at baseline of 34.3 is compared to the median of 11.0 at 12 months (versus the median of 11.6 at six months). ODI reduced by 68% when the median at baseline of 34.9 is compared to the median of 11.1 at 12 months (versus the median of 12.8 at six months). Further, after 12 months of treatment, OSPREY subjects in the device stimulation group experienced clinically meaningful improvements in the Epworth Sleepiness Scale (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ). ESS and FOSQ as compared to baseline are secondary outcome measures within the study. ESS is a patient questionnaire that assesses how likely the patient is to fall asleep during the day and FOSQ is a patient questionnaire that assesses the effects of fatigue on daily activities. "OSPREY is the first major multi-center randomized, controlled pivotal trial of hypoglossal nerve stimulation. Patients in the device stimulation group experienced a rapid onset of therapy with continued improvement over time,' said Dr. Atul Malhotra, lead investigator for the study, who is also a professor of medicine at University of California San Diego School of Medicine and sleep medicine specialist at UC San Diego Health. 'Responder rates in the treatment group were strong throughout the first year with one in four patients responding on day one, 50% responding by month three, and 65% responding by the 12-month mark. In addition, patient-reported outcomes for daytime sleepiness and functional outcomes of sleep quality demonstrated meaningful improvement over the course of 12 months.' Dr. Malhotra will present the OSPREY six-month results and 12-month top-line data at the American Thoracic Society International Conference on Tuesday, May 20, at 9:51 a.m. PDT in San Francisco. OSPREY baseline values of OSA severity and body mass index (BMI) were representative of the general OSA population. Relative to other large-scale trials of hypoglossal nerve stimulation (HGNS) in support of U.S. Food and Drug Administration (FDA) approval, OSPREY included patients with greater OSA severity and higher BMI. Plus, OSPREY was designed to include patients with complete concentric collapse (CCC). Based on a recently presented predictive algorithm 1, it was determined that the OSPREY study enrolled patients at increased risk of CCC at a ratio aligned with the general OSA population seen in clinical practice. Response rates and AHI reductions at month 12 for patients in OSPREY with predicted risk for CCC were consistent with the results for the full study population, demonstrating the robustness of the therapeutic response 2. 'The OSPREY trial demonstrated rapid and sustained improvement for patients who received active proximal hypoglossal nerve stimulation, including those with severe obstructive sleep apnea, elevated body mass index, and high risk of complete concentric collapse,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. 'The OSPREY 12-month results further validate the potential of this therapy as a treatment alternative for the large and growing OSA population. With the strength of our clinical data, expertise of our neuromodulation team, and strategic growth opportunity ahead, we are eager to bring this innovation to patients.' LivaNova recently completed its premarket approval submission to FDA for the aura6000 System based on meeting OSPREY's primary safety and efficacy endpoints following six months of treatment. LivaNova has also provided FDA with interim 12-month results from the OSPREY study and intends to share the full 12-month dataset with FDA during its review. The aura6000 System is an investigational implantable proximal hypoglossal neurostimulator undergoing clinical evaluation for the treatment of adult patients with moderate to severe OSA. There were no serious adverse device-related or procedure-related events reported during OSPREY. References The PREDICTOR algorithm was presented at the 2024 International Surgical Sleep Society Educational Update in Miami ( The presentation occurred on Friday, Sept. 27, 2024, with the lecture being delivered by Jordan Weiner, MD ( CYB-03127-R1 About OSPREY OSPREY is a prospective, multi-center, randomized controlled open-label trial evaluating the safety and efficacy of the aura6000™ System versus a no stimulation control in subjects with moderate to severe OSA who have failed or are unwilling to use positive airway pressure treatment. CAUTION—the aura6000 System is an investigational device. Limited by Federal (or United States) law to investigational use. 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 OSPREY study, the aura6000™ System, and presentations at upcoming conferences. 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.
