Medtronic Affera™ pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients
Medtronic (NYSE: MDT) announced positive clinical outcomes from two studies using their Affera™ family of technologies for atrial fibrillation treatment. The Sphere-360™ single-shot PFA catheter demonstrated 88% freedom from arrhythmia recurrence and 98% pulmonary vein isolation at one year, with no reported safety events in the optimized waveform group.
The Sphere-9™ catheter showed effectiveness for linear ablation in persistent AFib patients, based on sub-analysis from the Sphere Per-AF IDE study. The device received FDA approval in October 2024. Medtronic plans to begin U.S. pivotal trials for Sphere-360 later this year.
The company currently offers two PFA solutions: the PulseSelect™ system available in over 30 countries, and the Affera system with Sphere-9 catheter available in Europe, Australia, and New Zealand. AFib affects more than 60 million people worldwide and is a progressive disease that increases risks of heart failure, stroke, and death.
Medtronic (NYSE: MDT) ha annunciato risultati clinici positivi da due studi che utilizzano la famiglia di tecnologie Affera™ per il trattamento della fibrillazione atriale. Il catetere PFA monouso Sphere-360™ ha dimostrato un 88% di libertà dalla recidiva di aritmia e il 98% di isolamento delle vene polmonari a un anno, senza eventi di sicurezza segnalati nel gruppo con forma d’onda ottimizzata.
Il catetere Sphere-9™ ha mostrato efficacia nell’ablazione lineare nei pazienti con fibrillazione atriale persistente, secondo una sotto-analisi dello studio Sphere Per-AF IDE. Il dispositivo ha ottenuto l’approvazione FDA nell’ottobre 2024. Medtronic prevede di avviare entro quest’anno gli studi pivotali negli Stati Uniti per Sphere-360.
Attualmente l’azienda offre due soluzioni PFA: il sistema PulseSelect™, disponibile in oltre 30 paesi, e il sistema Affera con il catetere Sphere-9, disponibile in Europa, Australia e Nuova Zelanda. La fibrillazione atriale colpisce più di 60 milioni di persone nel mondo ed è una malattia progressiva che aumenta il rischio di insufficienza cardiaca, ictus e morte.
Medtronic (NYSE: MDT) anunció resultados clínicos positivos de dos estudios que utilizaron su familia de tecnologías Affera™ para el tratamiento de la fibrilación auricular. El catéter PFA de un solo disparo Sphere-360™ mostró un 88% de libertad de recurrencia de arritmias y un 98% de aislamiento de venas pulmonares a un año, sin eventos de seguridad reportados en el grupo con forma de onda optimizada.
El catéter Sphere-9™ demostró eficacia para ablación lineal en pacientes con fibrilación auricular persistente, según un subanálisis del estudio Sphere Per-AF IDE. El dispositivo recibió la aprobación de la FDA en octubre de 2024. Medtronic planea iniciar ensayos pivotales en EE. UU. para Sphere-360 a finales de este año.
Actualmente, la compañía ofrece dos soluciones PFA: el sistema PulseSelect™, disponible en más de 30 países, y el sistema Affera con el catéter Sphere-9, disponible en Europa, Australia y Nueva Zelanda. La fibrilación auricular afecta a más de 60 millones de personas en todo el mundo y es una enfermedad progresiva que aumenta el riesgo de insuficiencia cardíaca, accidente cerebrovascular y muerte.
메드트로닉 (NYSE: MDT)은 심방세동 치료를 위한 Affera™ 기술군을 사용한 두 건의 연구에서 긍정적인 임상 결과를 발표했습니다. Sphere-360™ 단일 사용 PFA 카테터는 1년 후 부정맥 재발률 12%로 88%의 재발 없음과 98%의 폐정맥 격리를 보여주었으며, 최적화된 파형 그룹에서는 안전성 문제 보고가 없었습니다.
Sphere-9™ 카테터는 지속성 심방세동 환자에서 선형 절제술의 효과를 입증했으며, 이는 Sphere Per-AF IDE 연구의 하위 분석 결과에 기반합니다. 이 장치는 2024년 10월 FDA 승인을 받았습니다. 메드트로닉은 올해 말 Sphere-360에 대한 미국 주요 임상시험을 시작할 계획입니다.
현재 회사는 두 가지 PFA 솔루션을 제공합니다: 30개국 이상에서 사용 가능한 PulseSelect™ 시스템과 유럽, 호주, 뉴질랜드에서 제공되는 Sphere-9 카테터가 포함된 Affera 시스템입니다. 심방세동은 전 세계 6천만 명 이상에게 영향을 미치며, 심부전, 뇌졸중 및 사망 위험을 증가시키는 진행성 질환입니다.
Medtronic (NYSE : MDT) a annoncé des résultats cliniques positifs issus de deux études utilisant leur gamme de technologies Affera™ pour le traitement de la fibrillation atriale. Le cathéter PFA monodose Sphere-360™ a démontré une liberté de récidive d’arythmie de 88 % et une isolation des veines pulmonaires de 98 % à un an, sans événements de sécurité rapportés dans le groupe avec forme d’onde optimisée.
Le cathéter Sphere-9™ a montré son efficacité pour l’ablation linéaire chez des patients atteints de fibrillation atriale persistante, selon une sous-analyse de l’étude Sphere Per-AF IDE. L’appareil a reçu l’approbation de la FDA en octobre 2024. Medtronic prévoit de lancer les essais pivotaux aux États-Unis pour Sphere-360 d’ici la fin de l’année.
L’entreprise propose actuellement deux solutions PFA : le système PulseSelect™, disponible dans plus de 30 pays, et le système Affera avec le cathéter Sphere-9, disponible en Europe, en Australie et en Nouvelle-Zélande. La fibrillation atriale touche plus de 60 millions de personnes dans le monde et constitue une maladie progressive augmentant les risques d’insuffisance cardiaque, d’accident vasculaire cérébral et de décès.
Medtronic (NYSE: MDT) gab positive klinische Ergebnisse aus zwei Studien bekannt, die ihre Affera™-Technologien zur Behandlung von Vorhofflimmern verwendeten. Der Sphere-360™ Einmal-PFA-Katheter zeigte nach einem Jahr eine 88%ige Freiheit von Arrhythmie-Rezidiven und eine 98%ige Pulmonalvenenisolation, ohne Sicherheitsvorfälle in der optimierten Wellenformgruppe.
Der Sphere-9™ Katheter erwies sich in einer Subanalyse der Sphere Per-AF IDE-Studie als wirksam für lineare Ablationen bei Patienten mit persistierendem Vorhofflimmern. Das Gerät erhielt im Oktober 2024 die FDA-Zulassung. Medtronic plant, noch in diesem Jahr die US-Zulassungsstudien für Sphere-360 zu starten.
Das Unternehmen bietet derzeit zwei PFA-Lösungen an: das PulseSelect™-System, das in über 30 Ländern verfügbar ist, und das Affera-System mit dem Sphere-9-Katheter, das in Europa, Australien und Neuseeland erhältlich ist. Vorhofflimmern betrifft weltweit mehr als 60 Millionen Menschen und ist eine fortschreitende Erkrankung, die das Risiko für Herzinsuffizienz, Schlaganfall und Tod erhöht.
- Strong clinical results: 88% freedom from arrhythmia recurrence and 98% PVI success rate
- Zero serious adverse events in Sphere-360 optimized waveform group
- FDA approval achieved for Sphere-9 catheter in October 2024
- Expanding global market presence with PFA solutions in 30+ countries
- Sphere-360 still in investigational phase, pending regulatory approvals
- geographical availability of Affera system (only in Europe, Australia, and New Zealand)
Insights
Medtronic's Affera PFA technologies show exceptional clinical results for AFib treatment with strong safety profiles and procedural advantages.
The one-year clinical data for Medtronic's Sphere-360 catheter demonstrates 88% freedom from arrhythmia recurrence and 98% chronically durable pulmonary vein isolation - metrics that represent excellent outcomes in the treatment of paroxysmal atrial fibrillation. Particularly notable is the complete absence of safety events in patients treated with the optimized waveform, addressing a critical concern in ablation procedures.
The Sphere-360's design offers distinctive technical advantages with its conformable lattice structure that creates circumferential lesions without catheter rotation, simplifying a traditionally challenging procedural step. Its 8.5 Fr sheath - described as the smallest among single-shot PFA technologies - potentially reduces access-site complications and patient discomfort.
The Sphere-9 catheter's demonstrated efficacy for linear ablation in persistent AFib represents important clinical versatility. Linear lesions are often critical for successful treatment of persistent AFib patients, who typically require more complex ablation strategies beyond standard pulmonary vein isolation.
Medtronic's dual-technology approach with both PulseSelect and Affera systems addresses the progressive nature of AFib, which the article notes affects
Medtronic strengthens its EP market position with clinically impressive Affera PFA technologies and clear global commercialization momentum.
Medtronic's reported clinical outcomes for its Affera technologies establish strong positioning in the electrophysiology (EP) market. The company is uniquely distinguishing itself as "the only company with two PFA offerings" - creating a diversified approach to the substantial atrial fibrillation market that affects more than
The commercial execution appears methodical and progressive. PulseSelect is already available in more than 30 countries, while the Affera system with Sphere-9 has established presence in Europe, Australia, and New Zealand with "global expansion ongoing." The clear regulatory pathway with FDA approval of Affera in October 2024 and planned U.S. pivotal trial for Sphere-360 later this year demonstrates structured portfolio advancement.
The technology's clinical utility across the AFib spectrum is particularly significant. As noted in the article, "AFib is a progressive disease," often advancing from paroxysmal to persistent forms with increasing risk of complications. The ability to address both stages with different catheter designs broadens Medtronic's addressable patient population.
The technology differentiation is noteworthy. Sphere-360's conformable design and small 8.5 Fr sheath, combined with Sphere-9's dual-energy capabilities for creating linear lesions, address specific procedural challenges that clinicians face with current technologies. This comprehensive approach with specialized tools for different ablation requirements positions Medtronic as an innovation leader in this therapeutic area.
- One-year clinical trial data for the next-generation, investigational, Sphere-360™ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
- Dual-energy (RF/PF), focal Sphere-9™ catheter demonstrates efficacy for linear ablation in persistent AFib
- Medtronic continues legacy of leadership in innovation, showcasing arrhythmia management portfolio at Heart Rhythm Society annual meeting
Sphere-360 Study Safety and Performance
Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in
"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in
Medtronic intends to begin its
Sphere-9 for Linear Ablation
Additionally, in a sub-analysis from the Sphere Per-AF IDE study, results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024.
"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel, president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."
Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelect™ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in
AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide.1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases2-5.
For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.
About Medtronic
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Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
References
- Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
- Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
- Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.- Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126
Dr. Reddy is a paid consultant for Medtronic.
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