Recently, a hospital in Texas used the Medtronic Affera platformCompleted the first case surgery in the United States.Just over a month ago, Medtronic's Affera Mapping and Ablation System was approved for marketing by the U.S. FDA, including the Sphere-9™ catheter and Affera™ Prism-1 mapping software., the system combines three functions: three-dimensional mapping (HD), radiofrequency ablation (RF), and pulsed field ablation (PFA).For the treatment of persistent atrial fibrillation and tricuspid isthmus-dependent atrial flutter, it received CE mark approval in March 2023.Accelerate CommercializationRecentlyOn November 7, the electrophysiology (EP) team at St. David's Medical Center's Texas Cardiac Arrhythmia Institute (TCAI) performed a procedure using Medtronic's Affera platform. The surgery, completed by Dr. Andrea Natale and Dr. Amin Al-Ahmad, marked the first commercial use of the Affera platform in the United States.
In the following weeks, more hospitals began using the Affera platform for surgeries, and it is expected that more patients will benefit from this innovative technology.New Technology.Affera Radiofrequency Ablation System and Sphere-9 Catheter Receive FDA Approval for Market Launch in the U.S., Making MedtronicThe First and OnlyA company with two pulsed field ablation (PFA) technologies available for the treatment of atrial fibrillation (AFib)(As of December 6, 2024)。Previously, Medtronic's PulseSelect PFA System received FDA approval in December 2023.Accurate.
In last month's Q2 financial report, Medtronic stated that it would enhance the commercial availability of the Affera mapping and ablation system.
Affera™ 3D Mapping and Ablation System
This is an integrated, dual-energy pulsed field (PF) and radiofrequency (RF) ablation system with high-density mapping capabilities, designed for cardiac electrophysiology ablation procedures.
Product Features of Sphere-9 are as follows:Three-in-one catheter,Combining high-density mapping, RF/PFA dual energy, allowing intraoperative mode switching without moving the catheter and connection lines, and meeting the ablation needs of different sites.
The lattice tip contains 9 microelectrodes.It is also a thermocouple. With a larger effective surface area, it can deliver higher current to the tissue at a lower current density, increasing the safe and effective window for ablation. It also provides real-time, precise temperature feedback and local impedance information.
Match3D Mapping System, with magnetic sensor.
Bidirectional Adjustable Bend, open perfusion, flexibly meeting the ablation needs of different parts and operational convenience.
Sphere-9 is equipped with inflatable conductive lattice electrodes. The catheter is inserted into the sheath in a folded form, but once it enters the heart, the lattice expands to a diameter of9mmThe spherical structure.
Prism-1 allows by using multiple position sensors at the tip.6 Degrees of FreedomPositioning for tracking and constructing a three-dimensional map of the chamber.Sphere-9 Lattice Ablation Catheter PairingHexaGen™ Ablation System and Saline Infusion Pump Use, combining both radiofrequency ablation and pulsed field ablation. This dual-generator design allows it to switch between radiofrequency energy and pulsed field energy without the need to move the catheter or connection lines, meeting the ablation needs of different sites.Related Research ProgressIn May 2024, Medtronic announced the results of a head-to-head clinical study (SPHERE Per-AF) at the 45th Annual Meeting of the Heart Rhythm Society (HRS) / Heart Rhythm Scientific Sessions, comparing its dual-energy ablation catheter and mapping system (Sphere-9 + Affera) with Johnson & Johnson's dual-energy ablation catheter and mapping system (Thermocool SmartTouch SF + Carto 3).
The results showed that Medtronic's mapping and ablation therapy had good safety, with a primary safety endpoint rate of1.4%(Johnson & Johnson is 1.0%).Received Medtronic mapping and ablation treatment 73.8% Patients did not experience recurrence of atrial fibrillation, while 65.8% of patients treated with Johnson & Johnson's regimen did not experience recurrence of atrial fibrillation.
After 100% acute isolation of pulmonary veins and linear lesions, receive Sphere-9 Catheter TherapyThe patients were also observed throughout the 12-month follow-up period.The recurrence rate of atrial arrhythmia is relatively low.。
Compared with the control group, the treatment efficiency was higher with the use of the Sphere-9 catheter.The time between the first ablation and the last ablationReduced by 26.8 minutes; Energy application time reduced by 28.6 minutes.On October 15, 2024, Medtronic announced that the early feasibility study of its Affera mapping and ablation system and Sphere-9 catheter in patients with ventricular tachycardia (VT) has received approval from the U.S. FDA.
This study will specifically focus on patients who have developed scar tissue due to a prior myocardial infarction (heart attack). Ventricular tachycardia is a potentially life-threatening abnormal heart rhythm that affects the lower chambers of the heart.
▲TextChapterComeSource:Global Health Industry Innovation Review▲Please indicate the source above when reprinting.Disclaimer: This article is intended solely for the purpose of information transmission and is for reference only. It does not constitute any advice on investment or treatment; please exercise caution. If there are issues related to the content, copyright, or other aspects of the work, to ensure the rights and interests of both parties, please contact us and we will address them immediately. If this article is reprinted by any platform, the platform must take responsibility for the content of the article; the Medical Device Innovation Network is not responsible for any secondary dissemination caused by reprints.
