Atrial Tachycardia

Emerging pulsed field ablation systems have made a major impact in the treatment of atrial fibrillation, with major medtechs receiving international approvals in the past year as newcomers wait in the wings. \n Emerging pulsed field ablation systems had their moments in the spotlight at the annual meeting of the Heart Rhythm Society (HRS), being held in San Diego this weekend. The therapy has made a major impact in the treatment of atrial fibrillation, the most common irregular heartbeat, with platforms from multiple major medtech companies receiving international approvals in the past year—including Medtronic, Boston Scientific and Johnson & Johnson. Pitched as a safer alternative to traditional ablations that use thermal energy, pulsed field ablation relies on quick bursts of electric fields to permanently disrupt the membranes of cardiac muscle cells that can drive arrhythmias—where the use of directed heat or cold may cause unintended damage to nearby organs and tissues. At the HRS meeting, Abbott presented 12-month data from a clinical study that backed the European approval of its Volt system, awarded last month. That trial included people with persistent afib lasting longer than a week, as well as those with paroxysmal, or intermittent, disease. After one year, 58.1% of treated patients with persistent afib were free of atrial arrhythmia symptoms, as were 83.5% of those with paroxysmal afib. The company said zero patients showed serious complications including hemolysis, coronary artery spasm, pulmonary vein stenosis, acute kidney injury or phrenic nerve injury—though 2.7% of Volt patients reported side effects logged by the trial. In addition, a separate sub-analysis showed no significant differences in safety or acute effectiveness in procedures performed under conscious or deep sedation, compared to those under general anesthesia.“Our goal from the beginning with the Volt PFA System was to design a PFA system that would provide outstanding results in patients battling a range of atrial arrhythmias, and the latest data from the Volt CE Mark Study is confirmation that the system will truly impact patient care in a positive way,” Christopher Piorkowski, chief medical officer of Abbott\'s electrophysiology business, said in a statement. At the same time, J&J delivered first-in-human results from an ongoing trial of its Omnypulse platform, featuring a large-tip catheter for focal pulsed field ablation. The Omny-IRE study included 136 patients with paroxysmal afib, and demonstrated 100% success in isolating the pulmonary vein using only five minutes of fluoroscopy time during the procedure. About 84% of those isolations remained secure when they were mapped again after three months. J&J received an FDA approval for its separate Varipulse system in November of last year, following green lights in Europe and Japan. Its initial U.S. rollout was paused in January following reports of four strokes among early patients; commercial efforts restarted in February, with the company recommending that clinicians avoid stacking repeated ablations in the same tissue. The meeting also saw Boston Scientific present new 12-month data from its Farapulse system, with its upcoming Farawave and Farapoint catheters, in patients with persistent afib. Farawave is being studied in pulmonary vein isolation and posterior wall ablation, while the adjunctive Farapoint is aimed at the cavotricuspid isthmus to treat atrial flutter.The trial, Advantage-AF, met its primary endpoints, with 73.4% of patients showing freedom from afib, flutter and atrial tachycardia. Additionally, 81% showed no afib recurrence—including no need for taking new anti-arrhythmic medications—and 96.4% of people treated with Farapoint had no recurrence of atrial flutter. Patients were also implanted with an insertable cardiac monitor.Farapulse is currently approved by the FDA for paroxysmal afib; Boston Scientific said it expects new green lights in persistent afib as well as for its Farapoint catheter in the latter half of this year. Meanwhile, Kardium presented 12-month data from a clinical trial of its novel Globe system. Its spherical catheter—three centimeters in diameter and studded with 122 gold electrodes—is designed to fit within the openings of the pulmonary veins and then isolate them from the atrium with a single shot, encircling ablation delivered from any angle. The company’s single-arm study included 183 patients; 78% showed no symptoms of intermittent afib after one year. Procedures took a total of about 95 minutes on average, including about 25 minutes for the ablations.The Globe system, using radiofrequency-powered thermal ablation, previously received a CE mark approval in Europe. The updated hybrid version of the device adds pulsed field capabilities, while incorporating heart-mapping technology. Kardium raised $104 million in venture capital funding in June of last year to help complete its development.  Newcomer Field Medical also showed off first-in-human findings of its platform aimed at treating ventricular tachycardia. In patients with scar-related v-tach—acquired after undergoing surgery or suffering a heart attack, among other conditions—78% demonstrated freedom from symptoms following treatment with the focal FieldForce system, while two of the 22 treated patients saw worsening heart failure.Field Medical recently posted a $40 million series A financing round to support two pilot studies, including one in afib, as well as preparation for a planned pivotal trial in v-tach. The company previously logged a $14 million seed round in September 2023. Finally, the HRS, in a joint statement with the American College of Cardiology, endorsed the development of protocols that would allow patients to be discharged the same day after undergoing a cardiac ablation procedure—including people treated outside of the hospital at ambulatory surgery centers.With afib increasing in prevalence across an aging population, same-day discharge strategies could help improve patient access and reduce the healthcare costs that come with overnight stays, they said—adding that data from the COVID-19 pandemic showed ablations could be safely performed in ASCs.However, the two groups cautioned that successfully implementing such a protocol would require close coordination of care with patients and caregivers, and that it should be based upon a shared decision-making process between the patient and physician with a focus on safety and comfort.

Trial achieves positive results in the treatment of persistent atrial fibrillation MARLBOROUGH, Mass. and SAN DIEGO, April 24, 2025 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced positive 12-month primary endpoint results from the second phase of the ADVANTAGE AF clinical trial evaluating the use of the FARAPULSE™ Pulsed Field Ablation (PFA) System* and adjunctive use of the FARAPOINT™ PFA Catheter in patients with persistent atrial fibrillation (AF). Key findings from the study were presented at the second annual PFA Live Case Summit in San Diego and simultaneously published in Circulation. Continue Reading The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF) and is a unique new alternative to standard-of-care thermal ablation treatment. Persistent AF, which accounts for approximately 25%1 of all AF cases, is an abnormal, rapid heartbeat that lasts for at least seven days in a row and can lead to complications such as blood clots, stroke and heart failure. The second phase of the ADVANTAGE AF trial studied the FARAWAVE™ PFA Catheter for both pulmonary vein isolation (PVI) and posterior wall ablation (PWA) and the FARAPOINT PFA Catheter for cavotricuspid isthmus (CTI) ablation to treat typical atrial flutter (AFL), a type of heart rhythm disorder. All patients in the trial were continuously monitored after their procedure with the LUX-Dx™ Insertable Cardiac Monitor (ICM) System, which is designed to detect recurrence of cardiac arrhythmias and assess AF burden. Findings from the trial met all pre-specified safety and effectiveness endpoints and demonstrated: 73.4% freedom from AF, AFL and atrial tachycardia (AT), which exceeded the performance goal of 40% or higher. A safety event rate of 2.4% and no reports of pulmonary vein stenosis, atrio-esophageal fistula or phrenic nerve palsy which met the performance goal of 12% or lower. 81.0% freedom from symptomatic documented AF recurrence, which is defined as arrhythmia, clinical intervention or use of escalated or new Class I/III anti-arrhythmic drugs. 71.6% of patients had virtually no atrial arrhythmia (AA) burden, in which data shows lower AA burden can be associated with fewer clinical interventions and improvements in quality of life and 52% of patients had no residual AA events after the blanking period. 96.4% of patients treated with the FARAPOINT PFA Catheter had no recurrence of AFL. "Continuous rhythm monitoring in phase two of the ADVANTAGE AF study allowed for a detailed picture of patients' cardiac rhythm after ablation, including asymptomatic AF recurrence, which is not often captured in U.S. Food and Drug Administration clinical trial monitoring but is important for the ability to provide more individualized care to patients," said Vivek Reddy, M.D.**, director, Cardiac Arrhythmia Services, Mount Sinai Health System and Leona M. and Harry B. Helmsley Charitable Trust professor of medicine, Cardiac Electrophysiology, Icahn School of Medicine and study principal investigator. "The data collected in this trial continues to support the FARAPULSE PFA System as a safe and effective therapy, now with evidence highlighting positive results for its use in treating patients who suffer from persistent AF." This prospective, single arm trial included 255 patients enrolled at 29 U.S. sites who were treated with the FARAWAVE PFA Catheter, and of those, 141 patients also received CTI ablation with the FARAPOINT PFA Catheter for AFL. The FARAPOINT PFA Catheter is a navigation-enabled point catheter that uses a smaller ablation footprint to create focal and linear-shaped lesions and integrates with the Boston Scientific OPAL HDx™ Mapping System to provide visualization of catheter placement during procedures. "These positive study results are an important step forward in the continued innovation of the proven FARAPULSE PFA System and our broader portfolio of products that treat AF," said Brad Sutton, M.D., chief medical officer, AF Solutions, Boston Scientific. "The performance of the devices in this trial – the FARAPOINT and FARAWAVE PFA Catheters as well as the LUX-Dx ICM System – is an encouraging sign as we work towards expanding our portfolio to provide physicians with an even more robust toolset to treat the growing number of patients with AF." Boston Scientific anticipates U.S. Food and Drug Administration approval to expand the instructions for use labeling for the FARAPULSE PFA System to include persistent AF as well as European and U.S. regulatory approvals for the FARAPOINT PFA Catheter in the second half of 2025. Learn more about the ADVANTAGE AF study here. About Boston Scientific Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and connect on LinkedIn and X, formerly Twitter. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. 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CONTACTS: Becca Johnson Media Relations +1 (952) 994-8526 [email protected] Jon Monson Investor Relations +1 (508) 683-5450 [email protected] *CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Ablation of patients with persistent atrial fibrillation or ablation beyond pulmonary vein isolation are outside the labeled indication(s) for use of the FARAWAVE™ PFA Catheter with the FARAPULSE PFA System. The FARAWAVE™ NAV PFA Catheter was not used in this study. The second phase of the trial included the addition of studying the focal FARAPOINT™ Pulsed Field Ablation Catheter for cavotricuspid isthmus (CTI) ablation to treat typical atrial flutter, which is not available for sale. **Dr. Vivek Reddy is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release. 1Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014;6:213-220. doi: 10.2147/CLEP.S47385 SOURCE Boston Scientific Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MARSEILLE, France, April 8, 2025 /PRNewswire/ -- Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists, today announced the appointment of Bill Hoffman as Executive Chairman of its Board of Directors. Bill brings a track record of guiding innovative startups to global success. As former Chief Executive Officer of Inari Medical, Hoffman oversaw the company's growth from early-stage concept to a publicly traded company with over $500 million in revenue and a significant clinical impact in venous thromboembolism treatment. Inari Medical was acquired by Stryker for $4.9B in February 2025. "We are honored to welcome Bill Hoffman as Executive Chairman," said Théophile Mohr-Durdez, CEO and co-founder of Volta Medical. "Bill's experience building, commercializing, and scaling, disruptive medical technologies will be invaluable as we accelerate global access to our AI-driven solutions for cardiac ablation." "Volta's technology has demonstrated, for the first time in the history of ablation, a clinically important and statistically significant improvement in efficacy outcomes for patients with AFib", said Hoffman. "How cool is that? I am so excited to join the Volta team and mission to impact our patients in the most amazing ways". In addition to Bill's appointment, Volta's Board has also appointed Jerome Kalifa, MD, PhD to the role of Executive Vice Chairman. Dr Kalifa will also continue to serve in the role of Chief Medical Officer. "We are excited to work with Bill on this mission. We are committed to eliminating AFib, impacting as many patients as possible, as fast as possible," said Dr Kalifa. This leadership appointment follows the recent publication of the landmark TAILORED-AF clinical trial in Nature Medicine, which demonstrated that an AI-guided procedure using Volta's technology, in combination with conventional pulmonary vein isolation (PVI), resulted in significantly improved outcomes for patients with persistent atrial fibrillation compared to PVI alone. 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. It is estimated that only 15% of the eligible 2.5 million US patients with AF are currently being treated with catheter ablation.4 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 [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/j.amjcard.2013.05.063 [last accessed June 9, 2023] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED