Source: Heart Future; Editor: Sophia
Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently,Medtronic (NYSE: MDT)InThe 45th in 2024American Heart Rhythm Society (HRS) Annual Meeting / Heart Rhythm Scientific SessionsUp,Announced a matter regarding itsDual-Energy Ablation Catheter and Mapping System (Sphere-9 + Affera)AndJohnson & JohnsonDual-Energy Ablation Catheter and Mapping System (Thermocool SmartTouch SF + Carto 3)TheHead-to-HeadClinical Study (SPHERE Per-AF) Results。The results showed,Medtronic's Mapping and AblationThe treatment has good safety.，The primary safety endpoint rate was 1.4% (1.0% for Johnson & Johnson).；Also showed higher efficiency in the treatment procedure.(such as reduced operation time and energy application time);Undergoing Medtronic mapping and ablation therapy73.8% of patients did not experience recurrence of atrial fibrillation., while patients who received the Johnson & Johnson treatment regimen did not experience recurrence of atrial fibrillationOnly 65.8%。Sphere-9 combinesMapping, Navigation, and TherapyFunction, is a product that canDelivery of RF Energy and Electrical Pulse EnergyCatheters for ablation, allowing doctors to customize treatment plans according to patient needs during the ablation process.Currently, the design of most pulsed field ablation (PFA) catheters aims to achieve one-time pulmonary vein isolation, but lacks flexibility in ablating complex anatomical locations.Design of Sphere-9Capable of achieving one-time pulmonary vein isolation through a compressible lattice sphere at the tip, while also offering the flexibility of point-by-point ablation.。
Medtronic's products mainly include Sp in pulse ablation.here-9™ and PulseSelect.The Sphere-9 ablation catheter originated from Medtronic's acquisition of Affera for $925 million in early 2022.Before acquiring Affera, Medtronic already had its own FDA-approved ablation catheter — PulseSelect.It is reported that Affera, headquartered in Newton, Massachusetts, designs and manufactures cardiac mapping and navigation systems, as well as catheter-based cardiac ablation technologies, includingUsed to treat atrial fibrillation and other arrhythmiasThe differentiated focused pulsed field ablation platform.March 2023,Affera™ Mapping and Ablation System Receives CE Mark, Including Sphere-9™ Catheter and Affera™ Prism-1 Mapping Software。Although Medtronic's self-developed PulseSelect has received FDA and CE approval,However, the annular design of PulseSelect has some shortcomings in terms of fit with the pulmonary veins, single annular size (25mm), and large sheath size (10Fr)., which also puts PulseSelect at a disadvantage in its competition with Boston Scientific, Johnson & Johnson.But Sphere-360 can make up for the shortcomings of PulseSelect., and canTruly achieve one-shot complete ablation.And achieveIntegrated Ablation and Mapping, Zero Exchange, thereby greatly simplifying the surgical process and reducing operation time.The Sphere Per-A trial is a multicenter, randomized clinical trial designed to evaluate the efficacy of the Affera mapping and Sphere-9 catheter system in treating persistent atrial fibrillation.The trial group was treated with the Sphere-9+Affera catheter.，The control group was treated with Thermocoll SmartTouch SF+ Carto 3 catheter.In this trial, the subjects were randomly assigned in a 1:1 ratio, with a total of 420 patients recruited across 23 centers in the United States, the Czech Republic, and Israel.- The Sphere-9 catheter has good safety.，The primary safety endpoint rate was 1.4%.(The control group was 1.0%.)No safety events were reported, including pulmonary vein stenosis, esophageal events, or cardiac tamponade.
- More than 95% of Sphere-9 procedures utilized a single transseptal puncture, compared to 62% in the control group.。
- Sphere-9 Group73.8% The patient did not experience recurrence of atrial fibrillation., while the control group was only65.8 %。
- After 100% acute isolation of pulmonary veins and linear lesions, receiveSphere-9 Catheter TreatmentThe 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 Sphere-9 catheter.Presented as:The time between the first ablation and the last ablationReduced by 26.8 minutes; Energy Application TimeReduced by 28.6 minutes。
- Patients treated with the Sphere-9 catheter showed improvements in both physical and mental health, as well as in quality of life.
# Research Evaluation
Johnson & Johnson's Thermocoll SmartTouchSF+Carto 3 has always been a benchmark in the field of radiofrequency ablation for atrial fibrillation, especially Carto 3, which is the cornerstone of Johnson & Johnson's dominance in the electrophysiological ablation sector. However,As competition in electrophysiology technology becomes increasingly fierce, Johnson & Johnson's once dominant lead has started to be gradually caught up by newcomers.。
Boston Scientific has taken the lead over Johnson & Johnson in PFA technology, andMedtronic continues to increase R&D investment and launch joint products such as Sphere-9+Affera,It has also approached or even surpassed Thermocoll SmartTouch SF+ Carto 3.。
Of course, Johnson & Johnson is also upgrading Carto 3 and Thermocoll SmartTouchSF, and developing new ablation catheters to continue maintaining its leading position in this field. To stay ahead, Johnson & Johnson needs to further increase its investment in research and development. Meanwhile, we also look forward to seeingMedtronic, Boston Scientific and other latecomers are jointly promoting technological innovation and market development by increasing investment.。
# Sphere-360 Lattice Ablation Catheter
▲Source: Company official website
Sphere-360 is aNew 7F Multi-Segment Grid Spherical Catheter，Aimed at effectively providing pulmonary vein isolationIt 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 used in conjunction with the 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 connecting wires., which can meet the ablation needs of different parts.Sphere-9 Lattice Ablation SystemWith an inflatable spherical lattice electrode design, with an effective surface area 10 times larger than that of a standard flush electrode,Can provide higher energy transfer at lower current densities.。Product Advantages are as follows:：（1）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.（2）Lattice Tip Design, Unlike other circular anatomical pulmonary vein pulse ablation electrode designs, the lattice-tip design of Sphere-9 (with 9 microelectrodes) can provide point-by-point ablation and is also flexible for use in different anatomical locations, such as linear lesions.（3）Transmission of pulsed field energy using lattice-tip catheters offers 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 as continuous transmural after 35 days post-operation.。（4）Uniform and efficient delivery of electrical pulse energy，Unique lattice tip design with a larger effective surface area allows for lower current density, delivering higher current to the tissue and increasing the safe and effective window for ablation. It offers advantages when used in special areas such as ventricular muscle.
# THERMOCOL SMARTTOUCH SF Dual-Energy Catheter
▲Source: Company official website
THERMOCOL SMARTTOUCH SF is a porous-tip saline-irrigated ablation catheter, which isCombining THERMOCOL SMARTTOUCH Technology with SF Catheter Porous Infusion Technology. This catheter combinesContact Force SensingAndAdvanced Multi-Porous Tip Ablation Technology, and has stronger operability and torque for excellent control.THERMOCOL SMARTTOUCH SF The 56 saline infusion micropores evenly distributed at the distal end of the ablation catheter form a water film at the catheter tip, achieving uniform cooling.InRadiofrequency AblationReduce the temperature at the catheter tip during the process to ensure efficient delivery of radiofrequency energy while minimizing the formation of eschar and small thrombi.。THERMOCOL SMARTTOUCH SF compared to THERMOCOL SMARTTOUCH,Achieve Uniform Cooling at Half Flow Rate. Compared with the SMART-AF study,Surgical time and fluoroscopy time were reduced by 19% and 55%, respectively.。
Product advantages are as follows：- Allows active measurement of stable contact force and catheter tip direction;
Using precision springs to respond to contact force for consistent motion;
Send accurate position reference signals through position sensors and transmitter coils;
Promote consistent lesion formation;
- Improved outcomes through more stable catheter-tissue contact force.
# About Medtronic
Medtronic (NYSE: MDT), founded in 1949, is headquartered in Minneapolis, Minnesota, USA. As a global leading medical technology company, it has over 95,000 employees.
Medtronic's innovative solutions have expanded to more than 70 key disease areas, committed to providing lifelong treatment options for patients with chronic conditions. Every second, two patients worldwide benefit from Medtronic's medical technologies or therapies.Medtronic's main businesses includeCardiovascular, Medical Surgery, Neuroscience, and DiabetesFour business segments, includingThe highest proportion is cardiovascular.。What Does Medtronic Sell? A Comprehensive Overview of the Cardiovascular Product Line
Taking the 2023 financial report as an example, the company's total revenue was $31.227 billion, ranking first in revenue among global medical device companies. Among this, the cardiovascular business revenue was $11.573 billion, accounting for 37.06%, includingCardiac Rhythm and Heart Failure (CRHF), Structural Heart and Aorta (SHA), and Coronary and Peripheral Vascular (CPV)Three departments.
▲2023 Annual Report (Source: Company Official Website)
