Medtronic Announces Positive Clinical Results for Sphere-360 Lattice Ablation Catheter in Atrial Fibrillation Treatment

Apr 10, 2024 10:40 CST Updated 10:40

Medtronic

Chronic Disease Medical Device and Therapy Developer

Source of the article: Heart Future; Editor: Bai Xiaofei

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

Recently,Medtronic (NYSE：MDT）At the European Heart Rhythm Association (EHRA) 2024 ConferencePublication of Clinical Study Results on the Sphere-360 Lattice Ablation Catheter，Results Show Positive Safety and Efficacy Outcomes for Sphere-360。

Sphere-9 combinesMapping, Navigation, and Treatment Functions, isCurrentlyThe only catheter capable of delivering both RF energy and electrical pulse energy 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 toAchieve single-shot pulmonary vein isolation, but the ablation flexibility is insufficient in complex anatomical locations.The design of Sphere-9 can bothOne-time Pulmonary Vein Isolation Achieved with a Compressible Lattice Sphere at the Distal End, and also has the flexibility of point ablation.。

▲Source: Company's official website

Medtronic's products involving pulsed ablation mainly include Sphere-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, includingFor the treatment of atrial fibrillation and other arrhythmiasThe differentiated focused pulsed field ablation platform.

March 2023,The Affera™ Mapping and Ablation System has received the CE Mark, which includes the Sphere-9™ catheter and Affera™ Prism-1 Mapping Software.。

Although Medtronic's self-developed PulseSelect has received FDA and CE approval,However, the ring design of PulseSelect has some shortcomings in terms of its fit with the pulmonary veins, single ring size (25mm), and large sheath size (10Fr)., which also puts PulseSelect at a disadvantage in its competition with Boston Scientific and Johnson & Johnson.But Sphere-360 can make up for the shortcomings of PulseSelect., and canTruly achieve one-shot complete ablation,And achieveAblation and Mapping Integration, Zero Exchange, thereby greatly simplifying the surgical process and reducing operation time.

# Specific Research Results

This study is a prospective, single-arm, multi-center clinical trial, enrolling a total of 85 patients across three centers in Europe.

One year after surgery, 81.8% of patients had no arrhythmia.，In the subgroup receiving optimized and latest pulse configuration treatment,100% of patients were free from arrhythmia.。
The average ablation time was 10 minutes.
A Sub-Study on Remapping Procedures in Patients Receiving Optimized Pulse Therapy; 96% of Patients Showed Sustained Lesion Durability, and in All Pulmonary Veins (PV) Treated in This Group,99% of patients maintained pulmonary vein isolation 75 days after the initial surgery.。
The study also showed that the Sphere-360 catheter has a high level of safety.The incidence of major safety-related adverse events was zero., including esophageal events, pulmonary vein stenosis, phrenic nerve injury, or cardiac tamponade.

# Sphere-360 Lattice Ablation Catheter

▲Source: Company's official website

Sphere-360 is aNew 7F Online 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 company's already marketed PFA product line.

Sphere-9 Lattice Ablation Catheter used with HexaGen™ Ablation Generator and Saline Infusion PumpCombining 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 irrigation 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 Sphere-9's lattice tip design (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.

（3）Using a lattice-tip catheter to deliver pulsed field energy 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 and phrenic nerve; on the other hand,Linear block can reach 100% in the acute phase, and the lesion still presents as continuous transmural at 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.

# Preclinical Data Support

Hagai et al. studied the safety and feasibility of using lattice-tip catheters to deliver pulsed field energy.The experiment used Affera's Sphere-9™ lattice-tip catheter.

Step One, evaluated the feasibility of using this catheter to create linear block lines in the atria of 14 pigs, and assessed the impact of acute ablation on the phrenic nerve and esophagus;

Step Two, to assess the persistence of block two weeks after ablation, and the impact on the phrenic nerve and esophagus;

Step Three, compared the effects of PFA and RFA on the esophagus and phrenic nerve.

Results Show：Pulsed field energy was generated during the acute phase100% Linear BlockHistological analysis at 35 days post-operation also confirmed transmural injury.(Thickness: 0.4-3.4mm, Lesion Width: 10.9-27.4mm).PFA selectively affects myocardial cells, with no impact on blood vessels and nerves.Ablation was performed near the posterior atrium close to the esophagus, creating transmural damage without injuring the esophagus; meanwhile, there were no transient phrenic nerve paralysis incidents (<5 min).

▲Animal experiments verified the safety and feasibility of the system.

Ayelet and other scholars found through animal experiments that the catheter has higher safety and effectiveness in ventricular ablation.

The experiment used the pulsed field mode of the lattice-tip catheter and observed well-demarcated lesions on the ventricular myocardium, compared with conventional ablation catheters.While producing larger and deeper lesions, the risk of cardiac tamponade is also reduced.The main reason is that the lattice tip has a larger effective surface area, which can deliver higher current to the tissue at a lower current density, resulting in uniform and widespread lesions.

▲Validation of the Advantages in Ventricular Myocardial Use

# Analysis of Competing Products in China and Abroad

Boston Scientific (FARAPULSE）

FARAPULSE consists of three parts: the main unit FARASTAR, the ablation catheter FARAWAVE, and the sheath FARADRIVE.

FARASTAR: Utilizes bipolar and biphasic waveforms as well as proprietary pulses. The interface is easy to operate.Achieve pulmonary vein vestibule isolation with just three buttons.。

FARADRIVE: A 13Fr distal steerable sheath,Better navigate FARAWAVE to the vestibules of various pulmonary veins。

FARAWAVE: is a 12Fr diameter ablation catheter, itsThe distal end adopts a unique flower-shaped design., with a total of 5 "petals," each upper "petal" equipped with 4 electrodes. The slider button on the handle can control whether the distal end is in the "bud" or "fully bloomed flower" state. When the 5 "petals" are fully open, they appear as flat petals; if partially open, they form a three-dimensional basket shape, with the basket diameter adjustable via catheter extension and retraction.

FARAWAVE comes in two specifications, the main difference being the maximum diameter when the "flower" is fully open. The maximum diameters of these products are 31mm and 35mm, respectively.。

The Innovative Structural Advantages of FARAPULSE：Unique spline structure ablation catheter can adapt to different pulmonary vein morphologies, achieving stable contact, enhancing clinical operational flexibility, rapid energy delivery, improving surgical efficiency, and reducing patient discomfort; treatment is effective and long-lasting; it can help doctors effectively shorten the learning curve.

FARAPULSE ablates cardiomyocytes with a lower electric field injury threshold by using a proprietary waveform.Without damaging surrounding tissues(Although these tissues are also within the ablation range).

The FARAPULSE Pulsed Field Ablation System has accumulated relatively comprehensive clinical usage data, including immediate surgical outcomes and long-term follow-up outcome data. A relatively mature surgical operation process and parameter setting have been established, supporting its ability to bring benefits to patients.

Johnson & Johnson (Varipulse)

March 2024,Biosense Webster, a Johnson & Johnson company, announces submission to FDA, hoping that its first PFA product — Varipulse Pulse Field Ablation (PFA) — will receive pre-market approval. The submission includes data from the admIRE study.Currently, Varipulse Pulse Field Ablation (PFA) has been approved in Europe and Japan.

If this application is successful, Varipulse will become the third PFA system authorized for the treatment of atrial fibrillation (AFib).

Varipulse Composed of the Varipulse ablation catheter and TruPulse generator, it is also compatible with the Carto 3 cardiac three-dimensional mapping system.

Varipulse Ablation Catheter isDeveloped based on Johnson & Johnson's previous mapping catheter, the Lasso catheter, is the continuation of the Lasso catheter technology.

The ablation catheter has 10 electrodes on its circular tip, with an adjustable circular tip size (ranging from 25 to 35mm). The catheter can be bidirectionally deflected, with one side deflecting 180° and the other side 90°, making it suitable for use in all four pulmonary veins, including the right inferior pulmonary vein.

The TruPulse generator is a device used for cardiac ablation therapy.In the treatment of cardiac arrhythmiaProvide reliable power transmission and control, to achieve precise ablation effects。

This generator is typically used in conjunction with other ablation devices and catheters forGenerating Pulse Fields Inside the Heart, to perform precise ablation treatment on cardiac tissue.

It hasHighly precise energy control and regulation function, which can be customized according to the doctor's needs, thereby improving the effectiveness and safety of the treatment.

Carto 3 Utilizing advanced3D Imaging Technology, which can be used to perform real-time procedures on the patient's heart in the operating room.High-resolution mapping。It can accuratelyLocating Abnormal Electrical Activity in the Heart, and provide doctors with visual navigation and positioning information to guide cardiac ablation therapy.

Jinjiang Electronics (LEAD-PFA)

December 2023, Jinjiang ElectronicsLEAD-PFA Cardiac Pulse Field Ablation System and Pulsed FA Single-Use Cardiac Pulse Field Ablation CatheterReceived marketing approval from the National Medical Products Administration (NMPA)。

LEAD-PFA Pulsed Field Ablation System is aBased on magnetic positioning navigation and integrating 3D modeling, mapping, and ablation.The cardiac pulsed electric field ablation system. Unlike traditional ablation technologies such as radiofrequency and cryoablation, this system utilizes pulsed electric field technology to achieve precise and rapid ablation. The systemFaster ablation speed, shorter duration, lower requirement for catheter contact, significantly improving surgical efficiency.。

LEAD-PFA Cardiac Pulse Field Ablation SystemFeatures：

Impedance Self-Test，Safe Ablation:Impedance monitoring of internal and external loops ensures the safety of pulse delivery;
System Integration, Visual Ablation:Highly integrated system, no disconnection required, real-time potential, easy operation;
Ablation solutions are optional, efficient, and flexible:Multiple preset ablation protocols, simple and quick operation, flexible adaptation to different surgical scenarios;
Parameter Optimization, Excellent Patient Experience: Almost no muscle reaction, little pain response, and good patient cooperation.

PulsedFA Single-Use Cardiac Pulsed Field Ablation CatheterFeatures：

Catheter embedded with multiple magnetic sensors, paired with LEAD-Mapping 3D cardiac electrophysiological mapping system, the entire catheter operation is visible and traceable;
One Loop, Multiple Uses, can be modeled, mapped, ablated, and verified;
One Atrial Septal Puncture, Safe and efficient surgery;
Special electrode design to reduce arc and bubble formation, ensuring non-thermal ablation while improving patient tolerance; select electrodes for ablation based on the situation to achieve personalized treatment.

Maiv Micro Medical (nsPFA)

In August 2023, the product developed by Maiwei MedicalThe World's First Nanosecond Pulsed Electric Field Atrial Fibrillation Ablation (nsPFA) System Successfully Completes Enrollment for All Registrational Clinical Trials, the system isCurrently the world's only nsPFA product to enter registered clinical trialsnsPFA represents the future of pulsed field ablation (PFA) technology, addressing a series of clinical pain points associated with second-generation PFA technology.

The existing PFA cardiac ablation technologies (including Farapulse) all adopt the second-generation microsecond pulsed electric field ablation technology.During the surgery, high anesthesia requirements may arise due to issues such as patient tremors and muscle contractions, further increasing the difficulty of the procedure. Intraoperatively, blood discharge producing gas may elevate the risk of stroke. Post-surgery, there may be problems such as a high 1-year recurrence rate in patients or pseudo-isolation.These issues above severely impact the clinical promotion and commercialization process of PFA technology.。

The nsPFA Atrial Fibrillation Ablation System is the third-generation PFA technology specifically designed to address the existing issues with current PFA ablation technologies. The nsPFA product from Maiwei Medical,YesWorld's FirstPFA Cardiac Ablation System Capable of Outputting High-Repetition-Frequency Nanosecond-Level High-Voltage Pulses, which optimizes the treatment electric field distribution through nanosecond pulses, reduces muscle contraction, and improves surgical safety, addressing the current challenges of severe muscle contraction and high anesthesia requirements in PFA.Achieving PFA Ablation Surgery for Atrial Fibrillation Under Analgesia Alone`, laying a solid foundation for the large-scale clinical application of PFA technology.`

The Third Generation nsPFAAdvantages of the Technology:

Denovo EP (CardioPulserm）

Developed by Denuo ElectrophysiologyCardioPulse™ Pulsed Field Ablation Catheter Designed as a China First, itsAn integrated ablation electrode can achieve pulmonary vein contact with various anatomical shapes., performing high-quality electrical signal mapping while rapidly and safely ablating the pulmonary veins.

In December 2020, the CardioPulse pulsed ablation system completed the first pulsed ablation treatment for paroxysmal atrial fibrillation in Asia;In 2021, the CardioPulse™ Pulse Ablation System China registration clinical study was officially launched and completed the enrollment of 2 cases, marking that CardioPulse™ has officially entered the pre-market multi-center clinical research stage.Approved for entry into the special review process for innovative medical devices in May 2022。

CardioPulse™ Pulsed Field Ablation System has full independent intellectual property rights,The product's unique multi-screw structure facilitates the adjustment of different diameters, better adapting to variations in pulmonary vein anatomy., canPerform ablation within the pulmonary vein ostium and vestibule area without relying on a three-dimensional mapping system.; The ablation electrode has both ablation and mapping functions, with a streamlined operation process; pulsed-field ablation is non-thermal ablation, which is tissue-specific, avoiding conductive heat injury and barotrauma, and can minimize the risk of damage to the esophagus, nerves, and blood vessels.

Xuanyu Medical (Multi-channel Pulsed Electric Field Ablation System）

The multi-channel pulsed electric field ablation system consists of a pulsed ablation generator and a pulsed ablation catheter, and is mainly used forMinimally Invasive Interventional Treatment for Atrial Fibrillation, throughPulmonary Vein Electrical Activity Isolation by Pulsed Field Ablation, thereby achieving the therapeutic purpose.

The system releases high-voltage pulses to myocardial tissue,Achieve irreversible electroporation of myocardial cells in the target area。Xuanyu Medical's "Multi-Channel Pulsed Electric Field Ablation Device"Completed the first clinical trial in March 2022, with significant efficacy.。

Xinluitong (Pulsed Field Ablation System）

Compared with other products on the market, Xinluitong's pulsed electric field ablation system has differentiated advantages. According to reports, its pulsed electric field ablation systemUsing a spline basket ablation catheter, multi-channel simultaneous ablation and mapping can be achieved.。Rapid Continuous Circumferential Pulmonary Vein Isolation, synchronously detect electrical signals, convenient for the operator,No complex three-dimensional mapping required, making the surgical operation simpler and more convenient, and easy to promote,Has also significantly reduced the economic burden on patients.. In addition,Its pulsed electric field ablation system has an ablation depth of 3.5 millimeters, ranking at a world-leading level.。

In January 2023, the pulsed field ablation (PFA) system for atrial fibrillation treatment independently developed by Shanghai Xinluitong Life Technology completed two registration clinical trials, marking the official entry of Xinluitong Technology's PFA project into the registration clinical research enrollment phase.

Zhouling Medical (LomaPulseB）

LomaPulseB Pulsed Field Ablation Device is manufactured byPulse Field Ablation SystemAndPulse Ablation CatheterComposition.

Pulse Field Ablation System consists of a pulse ablation main unit, foot pedal switch,The operation screen and the surface ECG lead wires, among other components, make up the system.Among them, the main unit consists of a central control system, a real-time ECG signal detection module, and a pulse generation unit. When in use,The host outputs pulse electrical signals, which act on myocardial cells through the catheter used in conjunction, causing irreversible pore effects, thereby achieving atrial fibrillation treatment.。

LomaPulse® Pulsed Field Ablation Product AdoptedHigh-Voltage Electrical Pulse Energy for Myocardial Selective Ablation, applying its uniquely innovative catheter design technology, self-learning detection technology, and multi-modal polarization fusion ablation technology to the field of atrial fibrillation treatment,Further improved the efficiency and success rate of ablation procedures。

The system has the following advantages：

Targeted High-Precision Effective TreatmentThe treatment process only ablates the superficial layer of the airway mucosa, reducing the number of mucus-producing goblet cells without damaging adjacent tissues.
Safe and Controllable.Treatment through natural orifices with intuitive interventional surgical methods minimizes harm to patients. The pulsed electric field energy is controllable during the operation, ensuring a safe and controllable surgical process.
High treatment efficiency and rapid patient recoveryThanks to the low energy and targeted nature of pulsed electric fields, combined with conventional endoscopy, unilateral full lobe surgery takes only 30 minutes, with no significant adverse reactions, allowing free movement immediately after the operation.

Aikema (Pulsed Electric Field Ablation Solution）

Developed by AccuPathPulse Field Ablation System and CatheterCan expose cardiomyocytes toHigh-Voltage Electric Field in Short PulsesBelow, increase the permeability of the cell membrane to ions and macromolecules,Formation of nanoscale irreversible electroporation, and ultimately leading to apoptosis of myocardial cells. This revolutionary new ablation technology, due to its selectivity for tissue and non-thermal energy characteristics, canSignificantly Improve the Safety and Efficacy of Atrial Fibrillation Treatment。

Aikangmai's Pulse Ablation SystemFromCircular Multi-Level Variable Diameter PFA Ablation Catheter, To MoreChannel PFA Energy GeneratorHave all been fully independently developed and produced.。The pulse ablation system of Aikangmai canSupports 10-channel electrode ablation, achieving microsecond-level single-pulse ablation.。

Regarding the industry's heated discussion on issues such as the ablation depth of pulsed field ablation (PFA), AccuPulseAdopted a bipolar and biphasic design, which can focus the energy on the myocardium and reduce muscle contraction or fibrillation.At the same time, Aikema has also carried out detailed optimization of parameters such as pulse width and grouping design to enhance the effectiveness, safety, and tolerability of patient treatment.

The core barriers of the Aikema PFA system are mainly reflected in two aspects.First, the pulse ablation system of Aikema can release stable, high-precision steep pulses of high-voltage electricity in an extremely short period of time.Currently, the single-action time of AccuPulse PFA is less than 0.2 seconds., at a world-leading level; secondly, Aikangmai has found a set of optimal ablation pulse parameters suitable for atrial fibrillation ablation, especially for pulmonary vein isolation.

Far Mountain Medical (Pulse Field Ablation System）

AsFirst ApprovedPFA System Produced in China Entering the NMPA Innovative Medical Device Special Approval Process, Far Mountain Medical Pulsed Field Ablation SystemThe surgery can be performed under local anesthesia, achieving true non-thermal ablation., significantly improving the safety and effectiveness of atrial fibrillation ablation procedures.

Product Features:

Advanced AF Ablation Technology with Unique Gradient Electric Field Selection Characteristics, ensuring complete ablation of myocardial cells while avoiding complications such as nerve damage, atrioesophageal fistula, and pulmonary vein stenosis, with a low postoperative recurrence rate.
Unique lantern frame structure and ultra-fast discharge mode, simplified the surgical procedure and improved the ablation efficiency.
With full independent intellectual property rights, it has been granted a national invention patent., and has applied for international patents in multiple countries including Europe and Southeast Asia. The clinical trial has been reviewed and approved by the ethics committees of several well-known hospitals in China, and a multi-center clinical trial is currently being conducted across China.

At the same time, to improve the safety of PFA surgery,Far Mountain Medical is independently developing a dedicated three-dimensional mapping system.，To provide a complete 3D PFA solution。Clinically, existing three-dimensional mapping systems are mostly developed for procedures such as radiofrequency ablation, based on thermal ablation. However, the PFA system acts on myocardial cells, inducing apoptosis, which differs from the necrosis mechanism of cryoablation or thermal ablation and thus cannot be directly applied.The specialized three-dimensional mapping system for Far Mountain Medical will further enhance the safety of PFA procedures.

# About Medtronic

Medtronic (Medtronic, NYSE: MDT) was founded in 1949, with its headquarters in Minneapolis, Minnesota, USA. It is a global leading medical technology company, employing over 95,000 people.

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 Surgical, Neuroscience, and DiabetesFour business blocks, 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. Revenue from the cardiovascular business 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)

# Global Leading Cardiovascular Device Company

Medtronic｜J&J MedTech|Boston ScientificBoston Scientific|

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