Abbott Receives CE Mark for its Volt™ Pulsed Field Ablation System to Treat Patients with Abnormal Heart Rhythms
Abbott (NYSE: ABT) has received CE Mark approval in Europe for its Volt™ PFA System, designed to treat atrial fibrillation (AFib). The system has begun commercial cases in the EU following strong clinical trial results showing 99.1% success rate in pulmonary vein isolation.
The Volt PFA System offers a single-catheter approach for mapping, pacing, and ablating, integrating with Abbott's EnSite™ X EP system. Key features include simplified workflow, efficient energy delivery through a proprietary balloon-in-basket design, and procedural flexibility allowing for light sedation or general anesthesia.
The approval comes as approximately 8 million Europeans over 65 live with AFib, a number expected to double in 30 years. The system is currently under evaluation in the VOLT-AF IDE Study with nearly 400 patients enrolled, with 12-month follow-up expected later this year.
Abbott (NYSE: ABT) ha ricevuto l'approvazione CE in Europa per il suo Volt™ PFA System, progettato per trattare la fibrillazione atriale (AFib). Il sistema ha avviato casi commerciali nell'UE dopo risultati promettenti negli studi clinici, con un tasso di successo del 99,1% nell'isolamento delle vene polmonari.
Il Volt PFA System offre un approccio a catetere singolo per la mappatura, la stimolazione e l'ablazione, integrandosi con il sistema EnSite™ X EP di Abbott. Le caratteristiche principali includono un flusso di lavoro semplificato, una consegna energetica efficiente attraverso un design proprietario a pallone in cesta e flessibilità procedurale che consente sedazione leggera o anestesia generale.
L'approvazione arriva in un contesto in cui circa 8 milioni di europei over 65 convivono con l'AFib, un numero che si prevede raddoppierà nei prossimi 30 anni. Il sistema è attualmente in fase di valutazione nello studio VOLT-AF IDE, con quasi 400 pazienti arruolati e un follow-up di 12 mesi previsto per la fine di quest'anno.
Abbott (NYSE: ABT) ha recibido la aprobación de marcado CE en Europa para su Volt™ PFA System, diseñado para tratar la fibrilación auricular (AFib). El sistema ha comenzado a realizar casos comerciales en la UE tras resultados clínicos sólidos que muestran una tasa de éxito del 99,1% en el aislamiento de las venas pulmonares.
El Volt PFA System ofrece un enfoque de catéter único para mapeo, estimulación y ablación, integrándose con el sistema EnSite™ X EP de Abbott. Las características clave incluyen un flujo de trabajo simplificado, entrega eficiente de energía a través de un diseño propietario de globo en cesta y flexibilidad en el procedimiento que permite sedación ligera o anestesia general.
La aprobación llega en un momento en que aproximadamente 8 millones de europeos mayores de 65 años viven con AFib, un número que se espera que se duplique en 30 años. El sistema está actualmente en evaluación en el estudio VOLT-AF IDE, con casi 400 pacientes inscritos, y se espera un seguimiento de 12 meses más adelante este año.
Abbott (NYSE: ABT)는 심방세동(AFib) 치료를 위해 설계된 Volt™ PFA System에 대해 유럽에서 CE 마크 승인을 받았습니다. 이 시스템은 폐정맥 절제술에서 99.1%의 성공률을 보여주는 강력한 임상 시험 결과에 따라 EU에서 상업적 사례를 시작했습니다.
Volt PFA System은 Abbott의 EnSite™ X EP 시스템과 통합되어 매핑, 페이싱 및 절제를 위한 단일 카테터 접근 방식을 제공합니다. 주요 특징으로는 간소화된 작업 흐름, 독점적인 풍선-바구니 디자인을 통한 효율적인 에너지 전달, 경미한 진정이나 전신 마취를 허용하는 절차적 유연성이 포함됩니다.
이 승인은 약 800만 명의 65세 이상의 유럽인이 AFib와 함께 살고 있으며, 이 숫자는 30년 후 두 배로 증가할 것으로 예상되는 가운데 이루어졌습니다. 이 시스템은 현재 거의 400명의 환자가 등록된 VOLT-AF IDE 연구에서 평가 중이며, 12개월 후속 조사가 올해 말에 예정되어 있습니다.
Abbott (NYSE: ABT) a reçu l'approbation du marquage CE en Europe pour son Volt™ PFA System, conçu pour traiter la fibrillation auriculaire (AFib). Le système a commencé à réaliser des cas commerciaux dans l'UE après des résultats d'essais cliniques solides montrant un taux de réussite de 99,1 % dans l'isolement des veines pulmonaires.
Le Volt PFA System offre une approche à cathéter unique pour la cartographie, la stimulation et l'ablation, s'intégrant avec le système EnSite™ X EP d'Abbott. Les caractéristiques clés comprennent un flux de travail simplifié, une livraison d'énergie efficace grâce à un design propriétaire de ballon dans un panier, et une flexibilité procédurale permettant une sédation légère ou une anesthésie générale.
L'approbation intervient alors qu'environ 8 millions d'Européens de plus de 65 ans vivent avec l'AFib, un nombre qui devrait doubler dans 30 ans. Le système est actuellement en évaluation dans l'étude VOLT-AF IDE avec près de 400 patients inscrits, et un suivi de 12 mois est prévu plus tard cette année.
Abbott (NYSE: ABT) hat die CE-Kennzeichnung in Europa für sein Volt™ PFA System erhalten, das zur Behandlung von Vorhofflimmern (AFib) entwickelt wurde. Das System hat nach starken klinischen Studienergebnissen, die eine Erfolgsquote von 99,1% bei der Isolation der Lungenvenen zeigen, mit kommerziellen Fällen in der EU begonnen.
Das Volt PFA System bietet einen Ein-Katheter-Ansatz für Mapping, Pacing und Ablation und integriert sich mit Abbotts EnSite™ X EP-System. Zu den wichtigsten Funktionen gehören ein vereinfachter Arbeitsablauf, eine effiziente Energieübertragung durch ein proprietäres Ballon-in-Korb-Design und prozedurale Flexibilität, die leichte Sedierung oder Vollnarkose ermöglicht.
Die Genehmigung erfolgt zu einem Zeitpunkt, an dem etwa 8 Millionen Europäer über 65 Jahren mit AFib leben, eine Zahl, die sich in 30 Jahren voraussichtlich verdoppeln wird. Das System wird derzeit in der VOLT-AF IDE-Studie evaluiert, an der fast 400 Patienten beteiligt sind, und eine 12-monatige Nachuntersuchung wird später in diesem Jahr erwartet.
- Early CE Mark approval received ahead of expectations
- Strong clinical trial results with 99.1% success rate in pulmonary vein isolation
- Commercial launch already initiated in EU markets
- Efficient system requiring fewer energy applications compared to competitive PFA systems
- None.
Insights
Abbott's CE Mark approval for the Volt PFA System represents a significant advancement in atrial fibrillation treatment technology. The system's 99.1% success rate in pulmonary vein isolation with fewer energy applications than competing systems demonstrates remarkable clinical efficiency. This isn't merely an incremental improvement - it's a fundamental redesign addressing key limitations of first-generation PFA devices.
The proprietary balloon-in-basket catheter design solves two critical challenges: energy transfer efficiency and contact visualization. By integrating with Abbott's EnSite X EP system, physicians gain real-time contact assessment that overcomes the blind positioning limitations of existing PFA technologies. This integration enables a single-catheter approach for mapping, pacing, and ablating - streamlining what has traditionally been a multi-catheter procedure.
For patients and physicians, the clinical implications are substantial. PFA technology itself reduces the risk of collateral tissue damage compared to traditional thermal ablation methods, particularly beneficial for patients with complex anatomy. The system's procedural flexibility regarding sedation options (light sedation or general anesthesia) provides important adaptive capabilities across different clinical settings.
The ahead-of-schedule trial enrollment for both the European approval study and the ongoing US IDE study suggests strong physician interest and confidence in this platform. Abbott's simultaneous advancement of complementary technologies (focal PFA, introducer sizing) indicates a comprehensive electrophysiology ecosystem strategy rather than a single-product approach.
The earlier-than-expected CE Mark for Abbott's Volt PFA System strengthens the company's position in the rapidly growing electrophysiology market. With 8 million Europeans over age 65 currently living with AFib - projected to double over 30 years - this approval captures significant first-mover advantage in a substantial addressable market.
Abbott's strategic rollout is noteworthy - beginning commercial cases immediately with physicians already experienced with the system from clinical trials. This controlled initial deployment followed by broader expansion in H2 2025 allows for market penetration while optimizing the launch execution.
The system's technological differentiation (single-catheter approach, fewer energy applications, proprietary balloon-in-basket design) creates compelling value propositions for both hospitals and payers. The workflow efficiencies and reduced procedural complexity translate to potential cost savings and improved resource utilization for healthcare systems.
Perhaps most significant is Abbott's comprehensive portfolio approach. The simultaneous advancement of the Volt PFA System, focal PFA technology, and complementary delivery systems creates ecosystem advantages that strengthen competitive barriers. The ahead-of-schedule enrollment in the VOLT-AF IDE study suggests potential for accelerated US market entry, which would represent another significant catalyst.
This CE Mark approval should be viewed not as an isolated regulatory win but as part of Abbott's broader strategy to establish leadership in next-generation electrophysiology. With AFib treatment demand surging globally due to aging populations, this positions Abbott to capture growing procedure volumes while potentially commanding premium pricing for demonstrably superior technology.
- Abbott's Volt™ PFA System is designed to provide a new therapy option for people battling heart rhythm disorders such as atrial fibrillation
- Pulsed field ablation – or PFA – uses high energy electrical pulses for ablation procedures that may offer benefits to targeting and treating tissue in the heart
- Abbott's Volt PFA System is designed to overcome limitations of existing PFA systems, providing improved workflows and a clearer indication of contact between the Volt PFA catheter and targeted tissue
ABBOTT PARK, Ill., March 27, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it has received CE Mark in
Today, approximately 8 million Europeans over the age of 65 are living with AFib, a number expected to double over the next 30 years.1,2 People living with AFib face an increased risk of stroke, heart failure and death, and many rely on cardiac ablation to treat the condition effectively. The Volt PFA System builds upon Abbott's leading electrophysiology (EP) portfolio by providing a single-catheter PFA approach, improving workflow by allowing for mapping, pacing, and ablating with a single catheter to safely and effectively treat patients with AFib.
CE Mark approval for the Volt PFA System was granted based on strong results from Abbott's Volt CE Mark study, a global clinical trial conducted at centers in
Following approval, initial cases were completed by Prof. Helmut Puererfellner at Ordensklinikum hospital in Linz,
"The launch of Abbott's Volt PFA system marks a major milestone in the evolution of electrophysiology across
Volt™ PFA System: Driving New Advancement in the PFA Market
PFA works differently from traditional ablation approaches by delivering high energy electrical pulses to targeted areas of cardiac tissue causing abnormal heart rhythms. As a result, PFA can reduce the risk of damaging adjacent tissue in patients with complex disease or anatomy.
Yet current on-market competitive PFA systems have required several therapy applications with a catheter positioned in various locations due to a lack of visualization or contact assessment. By integrating with Abbott's EnSite™ X EP system, the Volt PFA System is designed to address such limitations and provide:
- Simplified workflow. The single-catheter integrated approach of the Volt PFA system improves clinical workflow and provides real-time contact visualization to help physicians position the catheter for therapy delivery.
- Efficient energy delivery. The proprietary balloon-in-basket design of the Volt™ PFA Catheter, Sensor Enabled™, allows for efficient energy transfer directly to the targeted tissue to stop the heart's erratic signals, minimizing the number of therapy applications needed.
- Procedural flexibility. Patients undergoing a minimally invasive ablation procedure with the Volt PFA Catheter, Sensor Enabled, can be placed under light sedation or general anesthesia based on physician and hospital preference.
In addition, the Volt PFA catheter's integration with EnSite X system allows for clearer visualization and navigation for accurate positioning of the Volt PFA catheter to treat tissue. The One System Solution provided by EnSite X can accommodate all EP procedures and compatible technologies.
"While PFA is a relatively new therapy option, we've incorporated lessons learned from first-generation devices and designed the Volt system to simplify PFA procedures while making them more efficient," said Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business. "Clinical data has also shown that the Volt catheter's cutting-edge design helps physicians achieve pulmonary vein isolation in fewer ablation attempts and less therapy applications for improved patient outcomes."
Clinical and Regulatory Progress Across Abbott's PFA Portfolio
Abbott's Volt PFA System is currently under evaluation in the VOLT-AF Investigational Device Exemption (IDE) Study. The study completed enrollment last year – four months ahead of the anticipated timeline. Nearly 400 patients are enrolled in the trial, and Abbott anticipates completing the 12-month follow-up for the study later this year.
In addition, the company has also made significant progress in clinical studies evaluating Abbott's focal PFA technology, which is designed to provide focused energy delivery for the creation of targeted lesions at specific points in the heart. Enrollment was recently completed ahead of schedule in Abbott's FOCALFLEX CE trial assessing the performance of the TactiFlex™ Duo Ablation Catheter, Sensor Enabled™. Enrollment is also underway in the FlexPulse IDE trial evaluating TactiFlex Duo in the
Abbott has also recently received regulatory approval in the
For
Agilis™ NxT Steerable Introducer, Dual Reach™
https://abbo.tt/Agilis_ISI
EnSite™ X EP System
https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/mapping-systems/ensite-x.html
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
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1 Fact Sheets for Press. European Society of Cardiology. (n.d.-a). https://www.escardio.org/The-ESC/Press-Office/Factsheets
2 Atrial fibrillation set to affect more than 14 million over-65s in the EU by 2060. European Society of Cardiology. (n.d.). https://www.escardio.org/The-ESC/Press-Office/Press-releases/Atrial-fibrillation-set-to-affect-more-than-14-million-over-65s-in-the-EU-by-2060
3 Tilz, R.R. (2025, January 17) Acute results demonstrate safety and effectiveness of balloon-based pulsed field ablation system for de novo PVI in PAF and PersAF [Late Breaking Presentation]. AF Symposium 2025,
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FAQ
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