Medtronic Completes First U.S. Procedures with FDA-Approved Affera Mapping and Ablation System Featuring Sphere-9 Catheter
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A hospital in Texas announced today,Their electrophysiologists completed the first surgeries in the U.S. using Medtronic's (NYSE: MDT) Affera platform.The Affera Mapping and Ablation System, equipped with the Sphere-9 catheter, received approval from the U.S. Food and Drug Administration (FDA) on October 24.
The first surgery was completed on November 7.
Electrophysiologists at St. David's Medical Center Texas Cardiac Arrhythmia Institute (TCAI) performed the procedure using the Affera system. The first procedure was completed on November 7 by Dr. Andrea Natale and Dr. Amin Al-Ahmad.
On October 24, Medtronic's Affera Mapping and Ablation System equipped with the Sphere-9 catheter received approval from the U.S. Food and Drug Administration (FDA).This approval makes Medtronic the first and only company to possess two pulse field ablation (PFA) technologies available for treating atrial fibrillation (AFib). The medical technology giant also manufactures the PulseSelect PFA System, which last year became the first PFA system to receive FDA approval.
Sphere-9 is Medtronic's focal catheter, offering doctors the option of delivering pulsed field (PF) and radiofrequency (RF) energy. It is fully integrated with the Affera mapping and ablation system. Medtronic states that the system enhances physician efficiency while delivering excellent safety and efficacy outcomes.
Dr. Natalia stated, "This first-of-its-kind integrated catheter allows physicians to map, ablate, and verify using a single catheter, enhancing workflow flexibility and efficiency, thereby achieving greater safety and effectiveness. As global innovations in cardiac arrhythmia treatment continue to evolve, the Texas Cardiac Arrhythmia Research Foundation is honored to lead the way in providing advanced treatments for patients in Central Texas and beyond."
First Integrated High-Definition Mapping and
Dual-Energy (Pulsed Electric Field and Radiofrequency) Ablation Catheter
October 24, 2024Medtronic announced that its Affera™ Mapping and Ablation System and Sphere-9™ catheter have received approval from the U.S. Food and Drug Administration (FDA). This is an integrated, high-density (HD) mapping, pulsed field (PF), and radiofrequency (RF) ablation catheter used to treat persistent atrial fibrillation (AFib) and for ablation-dependent cavotricuspid isthmus (CTI) atrial flutter.
This catheter is highly anticipated by electrophysiologists due to its innovation, proven safety and efficacy, improved workflow, and shorter learning curve.
Sphere-9 Catheter Features a Cutting-Edge Design, Offering Physicians Both PF and RF Energy Delivery Options, Fully Integrated with the Affera Mapping and Ablation System. The Sphere-9 Catheter Enhances Physician Efficiency While Ensuring Excellent Safety and Effectiveness Outcomes.
The approval of this product is based on the excellent results achieved in the pivotal SPHERE Per-AF study (opens in new window). This study was an FDA Investigational Device Exemption (IDE) trial that compared the Sphere-9 catheter with the Affera mapping and ablation system to the traditional Thermocool SmartTouch® SF radiofrequency ablation catheter and Carto™ 3 system. The Affera mapping and ablation system and Sphere-9 catheter also received the CE mark in March 2023 and were approved in Australia in September 2024. In October 2024, Medtronic announced the initiation of an early feasibility study (opens in new window) to evaluate the use of the Sphere-9 catheter in treating ventricular tachycardia (VT), a type of arrhythmia characterized by abnormally rapid beating of the heart's lower chambers.
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