Source of the article: HeartFuture; Editor: SophiaReprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently,Medtronic (NYSE: MDT)Announced that its subsidiaryAffera Mapping and Ablation SystemHas obtained the United StatesFDA ApprovalListed, includingSphere-9™ Catheter and Affera™ Prism-1 Mapping Software, the system brings together3D Mapping (HD), Radiofrequency Ablation (RF), Pulsed Field Ablation (PFA)Triple Function, UseFor the treatment of persistent atrial fibrillation and tricuspid isthmus-dependent atrial flutter, which had previously been granted in March 2023.CE MarkApproval.In addition, its Evolut FX+ Transcatheter Aortic Valve Replacement (TAVR)SystemHas also been obtainedCE MarkApproval，For the treatment of symptomatic severe aortic stenosis (AS), the systemIt had previously been obtained in March 2024.FDA Approval。Evolut FX+ Compared to the previous Evolut TAVR systemLarge opening size4 Times，To facilitate access to different anatomical structures of the coronary arteries.Notably, prior to acquiring Affera for $1 billion in 2022, Medtronic did not have its own mapping system. The recent approval of the Affera system has strengthened Medtronic's position to compete more effectively with the other three major players in the electrophysiology field (Boston Scientific, Johnson & Johnson, and Abbott).Medtronic Becomes the First Company Globally to Offer Two FDA-Approved PFA Systems for Treating Atrial FibrillationMedtronic's PulseSelect PFA System Received FDA Approval in December 2023.Medtronic will also launch products applicable toSphere-360 for Single Pulmonary Vein Ablation, which can adjust the shape of the electrode according to the patient's physiological structure, thusAdapting to various different pulmonary vein anatomical structures, perfectly integrated with the Affera mapping and ablation system, achieving low to zero fluoroscopy.
Affera Radiofrequency Ablation System, Sphere-9 Catheter, Evolut FX+ Transcatheter Aortic Valve (from left to right)
# Affera™ 3D Mapping and Ablation System
Medtronic's existing PFA products include those independently developed byPulSelect And the acquisition of AfferaAffera Mapping and Ablation System。
PulSelect delivers bipolar, biphasic pulse electric fields through a circular multi-electrode array catheter and has received FDA and CE approval.However, its annular design has some shortcomings in terms of pulmonary vein conformity, single annular size (25mm), and large sheath size (10Fr).，Also puts Medtronic at a disadvantage in its competition with Boston Scientific and Johnson & Johnson.。
Affera™It is an integrated, dual-energyPulse Field (PF) and Radiofrequency (RF) AblationSystem, with simultaneous capabilitiesHigh-Density MappingFunction, used for cardiac electrophysiology ablation procedures. The system includes aMapping/Ablation Catheter (Sphere-9), oneEnergy Generator (Capable of Delivering PFA and RF), one3D Mapping Software (Prism-1)。
Sphere-9 is aNew 7.5F Multi-Segment Grid Spherical Catheter, which can be used in conjunction with other Medtronic products, serving as a complement to the already marketed PFA product line.Sphere-9 Lattice Ablation Catheter is used with HexaGen™ Ablation Generator and Saline Infusion Pump.Combining Radiofrequency Ablation and Pulsed Field Ablation，This dual-generator design allows it to switch between RF energy and pulsed field energy without the need to move the catheter and connection lines., which can meet the ablation needs of different parts.Sphere-9 features an inflatable conductive lattice electrode and is inserted into the sheath in a folded form.Once inside the heart, the lattice expands into a spherical structure with a diameter of 9mm.The lattice contains 9 micro-electrodes/temperature sensors (diameter 0.7mm), evenly distributed across its surface.The effective ablation area is10x, in4-5 secondsCan complete 1 ablation within, with a radiofrequency ablation lesion width ofOver 19mm, Electric Pulse Ablation Lesion WidthMore than 17mm。 ▲ Johnson & Johnson THERMOCOL SMARTTOUCH SF Dual-Energy Catheter and Medtronic Sphere-9 Lattice Ablation CatheterAdvantages of Affera™ are as follows:：Radiofrequency/Pulsed Field Ablation Dual Mode：Allows intraoperative mode switching without the need to move the catheter and connection lines, meeting the ablation needs of different areas.
Lattice Tip Design:The lattice tip design of Sphere-9 (with 9 microelectrodes) is capable of delivering point-by-point ablation and can also be flexibly used in different anatomical locations, such as linear lesions.
With higher safety and efficacy:On the one hand, it selectively affects myocardial cells without damaging the surrounding blood vessels and nerves, and without causing injury to the esophagus or phrenic nerve; on the other hand,Linear block can reach 100% in the acute phase, and the lesion still presents continuous transmural after 35 days post-operation.。
Uniform and Efficient Delivery of Electrical Pulse Energy:Unique lattice tip design with a larger effective surface area delivers higher current to the tissue at a lower current density.Increase the Safe and Effective Window of Ablation, it has advantages when used in special areas such as ventricular muscle.
IDE Clinical Research Data:
The control group used the Johnson & Johnson dual-energy ablation catheter THERMOCOOL SMARTTOUCH SF with the CARTO mapping system (radiofrequency and pulse ablation).
The primary safety endpoint rate was 1.4% (1% in the control group).。No safety incidents reported, including pulmonary vein stenosis, esophageal events, or pericardial tamponade, demonstrating positive safety.
Sphere-9 Group Exhibited73.8% of patients without atrial fibrillation(AF), andThe control group observed only 65.8%.。
After 100% acute isolation of pulmonary veins and linear lesions, patients treated with the Sphere-9 catheter during the entire 12-month follow-up periodFewer recurrences of atrial arrhythmias were observed.。
Sphere-9 GroupEach surgery saves more than 25 minutes.。
Medtronic also announcedAffera Mapping and Ablation System to Begin Early Feasibility Study. This study aims to evaluate the effectiveness of the Sphere-9 catheter in treating patients with persistent ventricular tachycardia (VT).The study will primarily focus on the incidence of device- or procedure-related serious adverse events following ablation surgery, as well as the acute effectiveness of ablating target VT, with plans to follow up with patients for 6 months.
▲Affera™ Product Line
Medtronic's New Generation TAVR - Evolut FX+Applicable to patients with severe symptomatic aortic stenosis across all risk categories (extreme, high, moderate, and low)., which is in MedtronicThe 4th Generation TAVR – Upgraded from Evolut FX，The biggest highlight is solving the problem of coronary artery access.。Evolut FX+ retains the three radiopaque markers of Evolut FX.Provides a larger coronary artery access window, with an opening size four times that of the previous Evolut series.. This design of the Evolut FX+ provides more room for catheter maneuverability,In order to access the coronary arteries of different patients' anatomical structures。▲Comparison of the Two SystemsIn a randomized controlled clinical study comparing with surgical aortic valve replacement (the industry gold standard - SAVR), a total of 1,414 patients attempted implantation (730 TAVR; 684 SAVR). The results showed that, compared with SAVR, Evolut TAVR achieved favorable outcomes in the primary endpoint of all-cause mortality or disabling stroke over four years.At year 4, the risk of death or disabling stroke was reduced by 26% relative to SAVR at 14.1% with TAVR.。But overall, combined with the research of other scholars, the advantages of TAVR technology compared to traditional SAVR technology are not very significant.. At the same time,The innovation of TAVR product technology is becoming increasingly difficult.，Medtronic and Edwards are both fine-tuning their respective TAVR products.For example, Edwards’ SAPIEN series launched the Sapien 3 Ultra Resilia TAVR in 2022, which upgraded the bovine pericardial tissue (dry valve) and skirt compared to the previous generation. Medtronic's Evolut FX+, on the other hand, improved the delivery system and radiopaque markers.Medtronic also announced at the ACC2024 conference in April 2024Head-to-Head Clinical Study Between the Evolut Platform and the Edwards Sapien Platform，Evolut Reaches Non-Inferiority in Primary Endpoint of Clinical Outcomes(Evolut 9.4% vs. SAPIEN 10.6%, p<0.001). Evolut TAVR demonstrated superiority in the primary endpoint of valve performance and bioprosthetic valve dysfunction within one year (Evolut 9.4%, SAPIEN 41.6%, p<0.001).Although the TAVR market competition is becoming increasingly fierce, shifting from initially growing together to a head-to-head confrontation, the positive results of this study, combined with the previous positive outcomes of the head-to-head clinical study with SAVR,Enable Medtronic to take the initiative in market promotion and publicity.`, laying the foundation for the next step of expanding market share.`
Medtronic (NYSE: MDT), founded in 1949 and headquartered in Minneapolis, Minnesota, USA, is a global leading medical technology company with over 95,000 employees.Medtronic's main businesses includeCardiovascular, Medical Surgical, Neuroscience, and Diabetes BusinessesFour major parts, includingThe highest proportion is cardiovascular.。
On August 20, 2024, Medtronic announcedFirst Quarter Financial Report of Fiscal Year 2025, The financial report shows:
- Revenue was $7.9 billion (approximately 56.32 billion RMB), with adjusted revenue at$80 Billion，Reported growth of 2.8%, organic growth of 5.3%；
- GAAP net income was US$1.042 billion, GAAP diluted earnings per share (EPS) was US$0.80; non-GAAP diluted earnings per share was US$1.23.
Among them, the cardiovascular product portfolio:Revenue of $3.07 billion, a year-over-year increase of 5.5%, with organic growth of 6.9%。
