A new paradigm in electrophysiology: Medtronic receives FDA approval of Affera™ Mapping and Ablation System and Sphere-9™ Catheter
Medtronic (NYSE: MDT) has received FDA approval for its Affera™ Mapping and Ablation System with Sphere-9™ Catheter, making it the first company with two pulsed field ablation (PFA) technologies for atrial fibrillation treatment. The system combines high-density mapping with dual energy (pulsed field and radiofrequency) ablation capabilities for treating persistent atrial fibrillation and atrial flutter. The Sphere-9 catheter features a 9mm lattice tip and enables physician treatment flexibility with its wide area focal design. The approval follows successful results from the SPHERE Per-AF study and previous CE Mark and Australian approvals.
Medtronic (NYSE: MDT) ha ricevuto l'approvazione dalla FDA per il suo Affera™ Mapping and Ablation System with Sphere-9™ Catheter, diventando la prima azienda con due tecnologie di ablazione a campo pulsato (PFA) per il trattamento della fibrillazione atriale. Il sistema combina mappatura ad alta densità con ablatione a doppia energia (campo pulsato e radiofrequenza) per il trattamento della fibrillazione atriale persistente e del flutter atriale. Il catetere Sphere-9 presenta una punta a reticolo di 9 mm e offre ai medici flessibilità nel trattamento grazie al suo design a focale di ampia area. L'approvazione arriva a seguito di risultati positivi dello studio SPHERE Per-AF e delle precedenti approvazioni CE e australiane.
Medtronic (NYSE: MDT) ha recibido la aprobación de la FDA para su Sistema de Mapeo y Ablación Affera™ con Catéter Sphere-9™, convirtiéndose en la primera empresa con dos tecnologías de ablación de campo pulsado (PFA) para el tratamiento de la fibrilación auricular. El sistema combina mapeo de alta densidad con capacidades de ablación de doble energía (campo pulsado y radiofrecuencia) para el tratamiento de la fibrilación auricular persistente y el aleteo auricular. El catéter Sphere-9 cuenta con una punta de retículo de 9 mm y permite flexibilidad en el tratamiento por parte del médico gracias a su diseño de área focal amplia. La aprobación sigue a resultados exitosos del estudio SPHERE Per-AF y a anteriores aprobaciones de CE y australianas.
메드트로닉 (NYSE: MDT)은 스피어-9™ 카테터가 포함된 아페라™ 맵핑 및 절제 시스템에 대해 FDA 승인을 받았으며, 심방세동 치료를 위한 두 가지 펄스 필드 절제(PFA) 기술을 보유한 첫 번째 회사가 되었습니다. 이 시스템은 지속적인 심방세동 및 심방세동 치료를 위한 고밀도 맵핑과 이중 에너지(펄스 필드 및 고주파) 절제 기능을 결합합니다. 스피어-9 카테터는 9mm 메쉬 팁을 특징으로 하며, 넓은 면적 초점 디자인 덕분에 의사의 치료 유연성을 제공합니다. 이번 승인은 SPHERE Per-AF 연구의 성공적인 결과와 이전의 CE 마크 및 호주 승인에 따른 것입니다.
Medtronic (NYSE: MDT) a reçu l'approbation de la FDA pour son Système de Cartographie et d'Ablation Affera™ avec Cathéter Sphere-9™, devenant ainsi la première entreprise à disposer de deux technologies d'Ablation par Champ Pulsé (PFA) pour le traitement de la fibrillation auriculaire. Le système combine une cartographie haute densité avec des capacités d'ablation à double énergie (champ pulsé et radiofréquence) pour traiter la fibrillation auriculaire persistante et le flutter auriculaire. Le cathéter Sphere-9 est équipé d'une pointe en treillis de 9 mm et permet une flexibilité de traitement pour le médecin grâce à son design à zone focale large. L'approbation fait suite à des résultats fructueux de l'étude SPHERE Per-AF, ainsi qu'à des précédentes approbations CE et australiennes.
Medtronic (NYSE: MDT) hat die FDA-Zulassung für sein Affera™ Mapping and Ablation System mit Sphere-9™ Katheter erhalten, was das Unternehmen zur ersten Firma macht, die über zwei Technologien zur Ablation mit gepulstem Feld (PFA) zur Behandlung von Vorhofflimmern verfügt. Das System kombiniert hochdichte Kartierung mit dualen Energie (gepulstes Feld und Radiofrequenz) Ablationsfähigkeiten zur Behandlung von persistierendem Vorhofflimmern und Vorhofflattern. Der Sphere-9 Katheter verfügt über eine 9-mm-Gitterspitze und ermöglicht den Ärzten Behandlungsspielraum durch sein Design mit großflächigem Fokus. Die Genehmigung folgt auf erfolgreiche Ergebnisse der SPHERE Per-AF-Studie sowie auf vorherige CE- und australische Genehmigungen.
- First company to offer two FDA-approved PFA technologies
- Dual energy capability (PF and RF) in a single device
- System received multiple regulatory approvals (FDA, CE Mark, Australia)
- Addresses large market with 60+ million AFib patients worldwide
- Zero-fluoroscopy and zero-exchange workflow enhances efficiency
- None.
Insights
The FDA approval of Medtronic's Affera™ system represents a significant technological advancement in cardiac ablation. The system's dual-energy capability (both pulsed field and radiofrequency ablation) combined with HD mapping in a single catheter is a major innovation in the electrophysiology space.
The key differentiators include:
- First-of-its-kind all-in-one mapping and dual-energy ablation system
- Zero-fluoroscopy and zero-exchange workflow capabilities
- Demonstrated safety and efficacy in the SPHERE Per-AF trial
- Potential for expanded indications, with ongoing studies in ventricular tachycardia
This approval strengthens Medtronic's position in the
This approval significantly enhances Medtronic's competitive position in the fast-growing AFib treatment market. With over 60 million people affected by AFib globally, the market opportunity is substantial. The dual-technology platform addresses both paroxysmal and persistent AFib, expanding the addressable patient population.
The timing is strategic, following their PulseSelect™ system approval in December 2023. This creates a comprehensive portfolio that could help Medtronic capture greater market share from competitors like Johnson & Johnson and Boston Scientific. The system's workflow efficiencies could drive hospital adoption by potentially reducing procedure times and costs while improving outcomes.
- First-of-its-kind, all-in-one HD-mapping and dual energy (pulsed field and radiofrequency) ablation catheter
- Highly anticipated by electrophysiologists for its innovation and demonstrated safety and efficacy as well as improved workflow and short learning curve
- Now with two pulsed field ablation (PFA) offerings and a portfolio of electrophysiology solutions, Medtronic is shaping the future of arrythmia treatment today
GALWAY,
With this approval, Medtronic is now the first and only company with two PFA technologies available for patients with Afib. The PulseSelect™ Pulsed Field Ablation System, which was FDA approved in December 2023, offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) while the Affera 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.
"The significance of this innovative technology should be underscored; Affera is a game changer for treatment of Afib and atrial flutter," said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. "The Affera system provides physicians with one safe, effective and efficient solution to this common and increasing problem in heart disease that needs optimized solutions for patients. With a short learning curve for experienced physicians, the possibilities are boundless for the treatment of Afib."
With a trailblazing design, the Sphere-9 catheter offers physicians the option of both PF and RF energy delivery, fully integrated with the Affera Mapping and Ablation System. The Sphere-9 catheter enhances workflow efficiency for physicians while providing excellent safety and efficacy outcomes.
"The Affera system was designed to address procedural challenges faced by the electrophysiology community while maintaining a high standard of safety and efficacy for patients. By enabling a single transeptal, zero-fluoroscopy, and zero-exchange workflow, the Sphere-9 catheter uniquely integrates both mapping and ablation technologies, offering the flexibility to use either pulsed field or radiofrequency energy," said Doron Harlev, vice president of engineering for Cardiac Ablation Solutions at Medtronic and founder of Affera. "This marks an exciting milestone for the field, with Medtronic's robust innovation pipeline poised to drive continued progress."
The approval was based on excellent results demonstrated in the pivotal SPHERE Per-AF study, an FDA Investigational Device Exemption (IDE) trial, which compared the Sphere-9 catheter with the Affera Mapping and Ablation System to the conventional Thermocool SmartTouch® SF radiofrequency ablation catheter with the Carto™*3 System. The Affera Mapping and Ablation System and Sphere-9 catheter also received CE Mark in March 2023 and was approved in
"At Medtronic, we have a 75-year tradition of bringing disruptive innovation to market, guided by our mission and commitment to address the unmet needs of patients. With the approval of Affera, we are excited to bring a novel mapping and ablation solution to clinicians that is intended to make atrial fibrillation treatment safer, more effective, and more efficient," said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Medtronic Cardiovascular Portfolio. "The potential of Affera is limitless. We will continue to fulfill our commitment to innovation, including new indications, to advance cardiovascular care and improve patient outcomes."
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 paroxsymal 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 Affera and the Sphere-9 catheter, visit Medtronic.com.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway,
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.
*Thermocool SmartTouch and Carto are trademarks of Biosense Webster, Inc.
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