Latest news with #VoltaMedical
Yahoo
11-06-2025
- Health
- Yahoo
Volta Medical Announces U.S. Label Expansion for Volta AF-Xplorer™ to Include Pivotal TAILORED-AF Clinical Trial Data
Volta Medical Secures U.S. Label Expansion for Volta AF-Xplorer Artificial Intelligence (AI) decision support system, clinically proven to help physicians treat underserved patients with persistent atrial fibrillation. MARSEILLE, France, June 11, 2025 /PRNewswire/ -- Volta Medical, a health technology company on a mission to treat the underserved complex atrial fibrillation (AF) patient population through the use of intelligent, AI solutions, today announced a significant update to the U.S. labeling of its flagship system, Volta AF-Xplorer. The AF-Xplorer delivers real-time, AI-driven insights to electrophysiologists, enabling more patient-specific decision-making in catheter ablation procedures treating AF. Labeling will now include the groundbreaking clinical data from the landmark TAILORED-AF trial which showed significantly improved long-term outcomes in the treatment of persistent AF compared to standard-of-care. Persistent AF is among the most challenging cardiac arrhythmias and represents 3/4 of all patients suffering from AF. However, only 1/3 of catheter ablations are performed on this more progressed disease state, resigning many to live with the debilitating disease. 1,2 TAILORED-AF is a prospective, multicenter, randomized controlled trial comparing standard of care to the Volta AF-Xplorer AI-guided tailored ablation. Results are compelling: in the mITT population 88% of patients in the tailored arm were free from AF at 12 months, compared to just 70% of patients treated with standard pulmonary vein isolation (p<0.0001). The Volta AF-Xplorer is the first system in the history of electrophysiology to demonstrate level one evidence of improved efficacy outcomes for persistent AF patients. The study was published in Nature Medicine earlier this year. "This label expansion is an important step for Volta Medical, and for millions of patients living with persistent AF," said Theophile Mohr Durdez, CEO and co-founder of Volta Medical. "Clinical evidence now supports that Volta AF-Xplorer can assist physicians in improving outcomes for a vast and challenging arrhythmia population." For access to the new labeling, visit our website. About Atrial Fibrillation The American Heart Association (AHA) defines atrial fibrillation (AF) as a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications.3 Approximately 33 million patients worldwide are living with AF.4,5 Even though untreated AF doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke, many patients are unaware that AF is a serious condition. About TAILORED-AF TAILORED-AF is a prospective, multicenter, randomized controlled clinical trial designed to evaluate whether a personalized ablation strategy using the AI-driven AF-Xplorer system improves outcomes for patients with persistent AF. In the modified intention-to-treat population, 88% of patients in the tailored ablation arm were free from AF at 12 months (with or without antiarrhythmic drugs), compared to 70% in the PVI-only group (p < 0.0001). Acute AF termination occurred in 66% of procedures using AF-Xplorer versus 15% in the control group. Secondary endpoints further support the approach. At 12 months, more patients in the tailored ablation arm were free from any atrial arrhythmia after one or two procedures, with or without the use of antiarrhythmic medications following a 3-month blanking period (76% vs. 71%), though this difference was not statistically significant. Additionally, the proportion of patients free from any atrial arrhythmia after one procedure (with or without antiarrhythmic medications after the blanking period) was the same in both groups (60%). About Volta Medical Volta Medical is a health technology company developing artificial intelligence software solutions with the aim of assisting cardiac electrophysiologists during arrhythmia treatment procedures to improve clinical outcomes for patients. Founded by three physicians and a data scientist in 2016 in Marseille, France, the company's mission is to improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data. The Volta AF-Xplorer is a digital AI companion designed to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs) known as spatio-temporal dispersed EGMs during AF and atrial tachycardia procedures. The Volta AF-Xplorer has been engineered for versatility and its use has been demonstrated with the most popular AF mapping and recording systems, as well as with the most common ablation modalities. The solution is U.S. FDA 510(k) cleared and European CE Marked. Volta Medical has created the therapy awareness program "AI for AF" designed to educate the underserved AF patient community, for more information, visit Media ContactMolly Megna, Sr. Marketing ManagerVolta References 1. "Efficacy of Dofetilide in the Treatment of Atrial Fibrillation-Flutter in Patients With Reduced Left Ventricular Function" Ole D. Pedersen, et al.2. Kirchhof P, Calkins H. Catheter ablation in patients with persistent atrial fibrillation. Eur Heart J. 2017 Jan 1;38(1):20-26. doi: 10.1093/eurheartj/ehw260. Epub 2016 Jul 7.3. [last accessed June 9, 2023]4. Colilla S, Crow A, Petku W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol 2013; 112:1142–1147. DOI: 10.1016/ [last accessed June 9, 2023] View original content to download multimedia: SOURCE Volta Medical Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
15-04-2025
- Health
- Associated Press
Volta Medical Announces Presentations at Heart Rhythm Society 2025 in San Diego, CA, USA
MARSEILLE, France, April 15, 2025 /PRNewswire/ -- Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists in assessing complex cardiac arrhythmias such as atrial fibrillation (AF), today announced presentations to be made at the Heart Rhythm Society 2025 meeting in San Diego, April 24 to 27. In-person attendance and live online participation in a hybrid format will be available. These presentations include a Rhythm Theater featuring a panel of experts in the field. Volta's co-founder Dr. Clément Bars will present additional findings from the landmark TAILORED-AF clinical trial. Dr. John Hummel, an electrophysiologist at Ohio State University Wexner Medical Center and the primary investigator for the RESTART trial will present the trial's initial outcomes. Summary of Presentations: Volta Medical will spotlight its latest clinical and technological advancements at Heart Rhythm 2025 in a Rhythm Theater session, 'AI-Driven Innovation in AF Ablation Procedures.' The session will be moderated by Dr. Vivek Reddy of The Mount Sinai Hospital and feature expert panelists Dr. Tina Baykaner of Stanford Medicine, Dr. Paul Zei of Brigham and Women's Hospital, and Dr. Benjamin D'Souza of Penn Presbyterian Medical Center. The panel will discuss the expanding role of AI in complex AF cases, and the integration of pulsed field ablation. Dr. John Hummel will present acute and long-term outcomes from the RESTART trial, an international, multicenter, non-randomized interventional study evaluating outcomes in recurrent-AF patients who failed previous ablations and who are now undergoing Volta AI-guided ablation, to assess if patients will be AF-free, without antiarrhythmic drugs, 12 months after their procedure. This trial focuses on patients whose previous pulmonary vein isolation (PVI) is shown to still be isolated, which is a particularly difficult patient population to treat. Volta Co-founder Dr. Clément Bars will present new insights from the TAILORED-AF trial, a transatlantic, randomized controlled study that demonstrated the superiority of Volta's AI-guided strategy plus PVI over PVI alone in patients with persistent and long-standing persistent AF. His presentation will delve into how artificial intelligence was utilized throughout the trial, provide an overview of the evolution of the Volta AF-Xplorer™ technology across its different versions, and explain how the AF-Xplorer platform functions. These findings further highlight Volta's innovative and differentiated approach to treating a patient population often underserved by conventional ablation strategies. At booth #1511, Volta Medical will showcase live demonstrations of the AF-Xplorer, an AI companion that identifies spatio-temporal dispersed electrograms (EGMs). Designed to support clinical decision-making in complex ablations, AF-Xplorer represents a significant step forward in scalable, data-driven treatment of persistent AF—supporting Volta's growth in a large, global electrophysiology market. About Atrial Fibrillation The American Heart Association (AHA) defines atrial fibrillation (AF) as a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications.1 Approximately 33 million patients worldwide are living with AF.2,3 Even though untreated AF doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke, many patients are unaware that AF is a serious condition. About Volta Medical Volta Medical is a health technology company developing artificial intelligence software solutions with the aim of assisting cardiac electrophysiologists during arrhythmia treatment procedures to improve clinical outcomes for patients. Founded by three physicians and a data scientist in 2016 in Marseille, France, the company's mission is to improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data. The Volta AF-Xplorer is a digital AI companion designed to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs) known as spatio-temporal dispersed EGMs during AF and atrial tachycardia procedures. The AF-Xplorer has been engineered for versatility and its use has been demonstrated with the most popular AF mapping and recording systems, as well as with the most common ablation modalities. The solution is U.S. FDA 510(k) cleared and European CE Mark approved. Volta Medical has created a therapy awareness program AI for Persistent AF Care designed to educate the underserved AF patient community, for more information, visit Media Contact Molly Megna, Sr. Marketing Manager Volta Medical [email protected] References 1. [last accessed June 9, 2023] 2. Colilla S, Crow A, Petku W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol 2013; 112:1142–1147. DOI: 10.1016/ 3. [last accessed June 9, 2023] View original content to download multimedia: SOURCE Volta Medical
Associated Press
17-03-2025
- Health
- Associated Press
GE HealthCare expands invasive cardiology solutions portfolio with AltiX AI.i for elevated experience in catheterization lab and electrophysiology procedures
GE HealthCare (Nasdaq: GEHC) today announced the launch of the AltiX AI.i edition of Mac-Lab™, CardioLab™ and ComboLab™. The AltiX AI.i editions are designed to improve the user experience, elevating workflow in the cardiac catheterization (cath) lab and supporting even the most complex electrophysiology (EP) procedures. These latest editions offer new features that can streamline workflow and enhance interoperability, while upholding strong cybersecurity standards. Cardiovascular disease (CVD) has nearly doubled over the past three decades, affecting more than 500 million people worldwide. During this period, both deaths and disabilities due to CVD have been on the rise globally. 1 As cardiac cases continue to rise, there is an urgent need for tools that improve the efficiency of cardiac cath and EP procedures. Efficient diagnosis and therapy are key elements of addressing the growing demand for care. 'AltiX AI.i is built on more than two decades of experience, leadership and innovation in invasive cardiology to enhance cath labs and EP procedures and empower clinicians to deliver the best possible outcomes,' said Jyoti Gera, CEO, CardioVascular & Interventional Solutions, GE HealthCare. 'By automating routine tasks and streamlining workflow, AltiX AI.i allows clinicians to focus on what truly matters – providing exceptional patient care.' Mac-Lab for cardiac catheterization The AltiX AI.i edition of Mac-Lab recording system combines functionality with workflow optimization. Clinicians can adopt this solution to elevate the cath lab user experience. The integration of the diastolic pressure ratio (dPR) algorithm allows users to easily perform this measurement, and builds on its ability to capture diastolic hyperemia-free ratio (DFR) measurements. These measurements are used to assess the severity of coronary artery disease. Mac-Lab provides optional Cath Lab Command Center access with a large display, advanced video and layouts, and customized documentation tools for a better user experience. CardioLab for EP procedures For EP procedures, the AltiX AI.i edition of CardioLab offers improved signal quality for visualization of physiological signals using the Prucka™ 3 digital amplifier. Prucka 3 is a solution that reduces environmental noise, maintains high signal fidelity and provides new signal-filtering capabilities for more advanced evaluations. 2 The latest CardioLab edition showcases GE HealthCare's collaboration with Volta Medical, Volta Interface, which utilizes PruckaStream to share real-time data to inform its Volta AF-Xplorer™ decision support system. The feature is designed to support clinicians with real-time assessments using artificial intelligence (AI) to automatically assess areas believed to initiate or maintain atrial fibrillation drivers. For an optimal visual experience, users can also harness the EP Command Center. ComboLab for a comprehensive solution ComboLab seamlessly integrates EP and hemodynamic recording into a single system, offering versatile functionality for both cath lab procedures and EP exams. ComboLab merges the best of Mac-Lab and CardioLab to give clinicians a comprehensive solution to manage various cardiac procedures in one location. Its familiar interface and workflow ease the learning curve, and its capability to document and export diagnostic data helps capture more information at the point of care. 'The introduction of AltiX AI.i reinforces our commitment to advancing cardiac care. These improved solutions are designed to enhance diagnostic and therapeutic capabilities, which are crucial for diagnosing and treating various heart conditions,' said Arnaud Marie, General Manager, Interventional Solutions, GE HealthCare. 'This launch is an important step in our ongoing mission to equip healthcare providers with interventional solutions that evolve alongside their needs.' In recognition of its innovation and leadership, GE HealthCare was recently honored by Frost & Sullivan as the 2024 Company of the Year in the Global Next-Generation EP Labs Industry. This prestigious award highlights GE HealthCare's commitment to growth and excellence in the field. GE HealthCare will showcase the AltiX AI.i edition of Mac-Lab, CardioLab and ComboLab at the European Heart Rhythm Association (EHRA) 2025 annual congress taking place on March 30 - April 1 in Vienna, Austria and Heart Rhythm Society (HRS) 2025 annual meeting on April 24 - April 27 in San Diego. AltiX AI.i is available for order in the United States and will launch in global markets later this year. * Consult with your GE HealthCare sales representative for more information on the availability of AltiX AI.i in your country. For more information, visit: * AltiX AI.i is 510(k) cleared and CE mark pending. About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient's journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. GE HealthCare is proud to be among 2025 Fortune World's Most Admired Companies™. 1 Roth, G, Mensah, G, Johnson, C. et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990–2019: Update From the GBD 2019 Study. JACC. 2020 Dec, 76 (25) 2982–3021. 2 GE HealthCare Data on File Eric Tatro GE HealthCare +1 312 459 6140 [email protected] SOURCE: GE HealthCare Technologies Inc. Copyright Business Wire 2025. PUB: 03/17/2025 09:01 AM/DISC: 03/17/2025 09:02 AM
Yahoo
14-02-2025
- Health
- Yahoo
Volta Medical Artificial Intelligence-guided Cardiac Ablation Procedure Improves Treatment of Atrial Fibrillation
AI-Guided Cardiac Ablation in combination with pulmonary vein isolation was superior to the standard of care in the treatment of Persistent Atrial Fibrillation Volta Medical Announces Publication of Landmark Clinical Trial in Nature Medicine. This trial marks the first large-scale demonstration of the benefits of AI in interventional cardiology. MARSEILLE, France, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists, today announced the publication of the landmark TAILORED-AF clinical trial in Nature Medicine, which demonstrated that an AI-guided procedure for persistent atrial fibrillation (AF) in combination with conventional pulmonary vein isolation (PVI) treatment, resulted in better outcomes than PVI alone. In particular, the study showed superiority in the percentage of patients that achieved freedom from atrial fibrillation (AF) with or without anti-arrhythmic drugs at 12 months after a tailored cardiac ablation guided by AI in combination with PVI when compared to PVI alone. Despite advances in catheter ablation technology, persistent AF remains one of the most challenging subtypes of atrial fibrillation to treat, affecting over 70% of all patients with atrial fibrillation globally.i The TAILORED-AF clinical trial is the first large-scale transatlantic randomized controlled trial (RCT) of ablation in a persistent atrial fibrillation (AF) population to show the benefit of going beyond conventional pulmonary vein isolation (PVI)-only extra-pulmonary vein procedure. Previous studies looking at ablation strategies for persistent AF patients have not demonstrated superior efficacy to PVI alone. The Volta AF-Xplorer™ is a digital AI companion designed to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs) known as spatio-temporal dispersed EGMs, this technology was used in the TAILORED-AF trial. 'Previously, there has not been a replicable, effective treatment strategy for patients with persistent atrial fibrillation. Volta's AI solution finally offers a solution for this large and underserved patient population,' said Théophile Mohr-Durdez, CEO and co-founder of Volta Medical. 'The TAILORED-AF trial, highlights AI's ability to help physicians treat cardiovascular disease and improve patient outcomes. In fact, this is the first large-scale international RCT in interventional cardiology demonstrating superior efficacy through the use of AI.' Summary and Results: Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation (TAILORED-AF) Study In the clinical trial, adults with symptomatic persistent or long-standing persistent AF who were candidates for a first-time ablation were enrolled in Europe and the United States. A total of 187 patients underwent a tailored cardiac ablation guided by Volta's AI in addition to PVI (Tailored cohort), and 183 patients received the conventional treatment of PVI-only (Anatomical cohort) and all were followed up for 12 months. A total of 51 electrophysiologists at 26 centers in 5 countries across the US and the EU participated. For access to the full publication visit The trial met the primary endpoint by demonstrating superior results in patients assigned to the Tailored cohort compared to the Anatomical cohort. 88% of patients in the Tailored cohort experienced freedom from AF 12 months after one procedure with or without anti-arrhythmic drugs compared to 70% in the Anatomical cohort (log rank p < 0.0001). In the Tailored cohort, patients experienced a higher rate of freedom from any arrhythmia after 1.2 procedures than in the Anatomical cohort (79% vs. 71%, log rank p < 0.01). Recurrences in the Tailored cohort were regarded as a 'simplification' of AF which are generally easier to ablate and can be seen as a step towards stable sinus rhythm. The trial also examined several pre-specified secondary endpoints and a pre-specified subgroup analysis of patients with sustained persistent AF lasting 6 months or longer prior to enrollment. These patients represent a more advanced AF disease progression. Patients in the Tailored cohort experienced a significantly higher rate of freedom from any arrhythmia after one single procedure than in the Anatomical cohort (62% vs. 48%, log rank p = 0.04). The safety endpoint did not differ between the groups, although the procedure and ablation time were twice as long in the Tailored arm, consistent with treatment time for other PVI+ methods. 'Atrial fibrillation, when left untreated, doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke. However, advancements in AI are transforming this landscape,' said Seth Goldbarg, MD, FACC, FHRS, Cardiologist, NewYork-Presbyterian, Queens. 'This trial featuring AI-guided assessment of AF represents a true milestone for improvement of outcomes for this underserved and difficult to treat patient community.' About Atrial Fibrillation The American Heart Association defines AF as a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure, and other heart-related Approximately 33 million patients worldwide are living with Even though untreated AF doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke, many patients are unaware that AF is a serious condition. It is estimated that only 15% of the eligible 2.5 million US patients with AF are currently being treated with catheter ablation.v About Volta Medical Volta Medical is a health technology company developing artificial intelligence software solutions with the aim of assisting cardiac electrophysiologists during arrhythmia treatment procedures to improve clinical outcomes for patients. Founded by three physicians and a data scientist in 2016 in Marseille, France, the company's mission is to improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data. The Volta AF-Xplorer™ is a digital AI companion designed to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs) known as spatio-temporal dispersed EGMs during AF and atrial tachycardia procedures. The AF-Xplorer™ has been engineered for versatility and its use has been demonstrated with the most popular AF mapping and recording systems, as well as with the most common ablation modalities. The solution is U.S. FDA 510(k) cleared and European CE Mark approved. For more information, visit the company's website at Volta Medical has created a therapy awareness program AI for Persistent AF Care designed to educate the underserved AF patient community, for more information, visit U.S. Media ContactGlenn SilverFinn ContactJeff Martin, SVP of Global MarketingVolta Medical References David DeLurgio, Jaswinder Gill, Syed Ahsan, Riyaz Kaba, Kristen M Plasseraud, Michael E Halkos, Hybrid Convergent Procedure for the Treatment of Persistent and Long-standing Persistent Atrial Fibrillation, Arrhythmia & Electrophysiology Review 2021;10(3):198–204. [last accessed June 9, 2023] Colilla S, Crow A, Petku W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol 2013; 112:1142–1147. DOI: 10.1016/ [last accessed June 9, 2023] in to access your portfolio
