Johnson & Johnson's Dual-Energy Ablation Catheter Achieves 100% Acute Success in SmartfIRE Trial

Apr 14, 2024 15:36 CST Updated 15:36

Johnson & Johnson

Medical Device R&D and Manufacturer

Medtronic

Medical Device Manufacturer

Source: 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 to the Future

Recently,Johnson & Johnson (NYSE：JNJ）At the European Heart Rhythm Association (EHRA) 2024 conference, a study was announced regardingTHERMOCOL SMARTTOUCH SF Dual-Energy Ablation Catheter First Clinical Study (SmartfIRE) Results`, the results showed`The acute success rate of the dual-energy ablation catheter was 100%.。

This device is produced by a subsidiary of Johnson & Johnson.Biosense WebsterProduction,It is generally believed in the industry that,THERMOCOL SMARTTOUCH SF Dual-Energy Catheter is a response to Medtronic's acquisition of Affera for $1 billion last year.By acquiring Affera, Medtronic has obtained the ablation product Sphere-9, which features electropulse, radiofrequency, and mapping capabilities.

THERMOCOOL SMARTTOUCH SF, with contact force sensing capability, is a steerable multi-electrode irrigated catheter.TRUPULSE Generator switches between two energy sources on the generator display to deliver energy to this catheter.Provide RF energy and monopolar biphasic pulse sequencesThe THERMOCOOL SMARTTOUCH SF catheter will be used together with the TRUPULSE generator.For cardiac ablation, enabling pulse or radiofrequency energy to be transmitted to the catheter tip electrode.

▲Source: Company's official website

Medtronic (NYSE: MDT) also announced the clinical study results of the Sphere-360 Lattice Ablation Catheter at the European Heart Rhythm Association (EHRA) 2024 conference.Results Show Positive Safety and Efficacy Outcomes for Sphere-360. (For details, see:Latest Research Released! Medtronic Dual-Energy AF Ablation Catheter）

# Specific Research Results

SmartfIRE is a pivotal, prospective, multi-center, single-arm study that will enroll approximately 137 patients in Europe to evaluate THERMOCOL SMARTTOUCH SF+TRUPULSE.Safety and Efficacy of Dual-Energy Electrical Pulse/Radiofrequency (RF) Ablation。

The test results showed：

Drug ResistanceParoxysmal Atrial FibrillationThe treatment has achieved100% Acute Success, and has a high persistence of pulmonary vein isolation (PVI).
When used for atrial-pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (N=137),The median ablation time was 12.8 minutes, and the fluoroscopy exposure time was 4.2 minutes.。
A pre-specified remapping of a subset of patients at 75 (+/-15) days post-surgery showed,87% of the targeted veins were persistently isolated.。
4.4% of patients experienced major adverse events.

# 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 Multi-porous Perfusion 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.Reduce the catheter tip temperature during the radiofrequency ablation 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;
Utilizes precision springs to respond to contact force, providing consistent motion;
Send accurate position reference signals through position sensors and transmitter coils;
Promote consistent lesion formation;
Reduce ablation time;
Improve outcomes through more stable catheter-tissue contact force.

# Left Hand Gathers Momentum, Right Hand Adds Weight

As early as 1996, Johnson & Johnson acquired Cordis and Biosense for $1.8 billion and $400 million, respectively, andCordis WebsterMerged with Biosense to become today's Biosense Webster.

First, let's look at Cordis,Since bringing the world's first guiding catheter in 1966, Cordis has pioneered multiple "firsts" in vascular interventional procedures., including the first sheath, the first bare stent, etc., at the time of its acquisition by Johnson & Johnson in 1996, Cordis had already captured 11% of the global vascular intervention market.

At that time, Cordis's core products, catheters and angioplasty balloons, were micro-metal devices used to support open blood vessels in the heart, which would help further enrich Johnson & Johnson's cardiac stent product line and expand its competitive advantage.

Another important component of Biosense WebsterBiosense was founded in 1993 by Harvard University, and the company focuses on electrophysiological mapping catheters.。

In 1995, Biosense launched the world's first cardiac3D Electrophysiological Mapping System, although at that time Biosense was still small in scale, the leading nature of its products had already begun to show.

Acquiring Biosense was a crucial step for Johnson & Johnson to establish its leadership position in the global 3D mapping products market.The rapid development of Biosense Webster today also proves that Johnson & Johnson made the right choice back then.。

Past efforts have laid a solid foundation for Johnson & Johnson's electrophysiology business, and years of outstanding performance have made the company increasingly focus on its strategic layout in the electrophysiology field.。

In August 2023, Biosense Webster, a subsidiary of Johnson & Johnson Medical, officially announced itsMultiple Market-Leading Cardiac Ablation Products Receive FDA Approval for Zero-Fluoroscopy Workflow。

This means Johnson & Johnson has become the currentThe world's first and only FDA-approvedCompany Using AFib Ablation Products in Non-Fluoroscopic Workflows, thus ushering in a new era of atrial fibrillation ablation.

The message shows that the products covered by this process include multiple products under Johnson & Johnson, such asTHERMOCOOL SMARTTOUCH™ SF CatheterTHERMOCOOL SMARTTOUCH™ Catheter, CARTO® VIZIGO® Bidirectional Guiding Sheath, PENTARAY® NAV ECO High-Density Mapping Catheter, DECANAV® Mapping Catheter, and Webster® CS Catheter.TThe HERMOCOOL SMARTTOUCH™ SF Catheter is one of the most commonly used radiofrequency ablation catheters in the world.）

As the main method currently used to treat arrhythmia, catheter ablation has significant advantages such as minimal trauma and fast patient recovery, butThe high radiation issue caused by intraoperative X-ray fluoroscopy guidance has long been a concern for both doctors and patients.。

To reduce the cancer risk caused by high radiation exposure, doctors have to wear heavy personal protective equipment (such as lead aprons) for prevention. However, this inevitably leads to musculoskeletal pain for the users.

The new workflow approved by the FDA will make direct imaging guidance, such as ultrasound, an alternative to fluoroscopy, thereby relieving doctors of the heavy burden during surgery.。

As Johnson & Johnson Biosense Webster PresidentJasmina BrooksAs mentioned, "the FDA approval of this label change will enhance the safety and efficiency of cardiac ablation and further strengthen the advantages of the department's product portfolio."

For the electrophysiology department with strong performance growth, it is like adding wings to a tiger.

About Biosense WebsterCompany

Biosense Webster isJohnson & JohnsonIn 1996, respectively, for 1.8 billion US dollars and 400 million US dollarsMerger after the acquisition of Cordis Webster and BiosenseThe company, which has since arrived, is currently solely responsible.Johnson & Johnson's electrophysiology business is dedicated to the research and development of electrophysiological interventional diagnosis and treatment products.

Biosense, with its excellent and innovative technology, is a world leader in 3D mapping systems and software. It is also the inventor of the world's first deflectable catheter.

The company's products are divided into six categories:3D Navigation System, Diagnostic Catheter, Therapeutic Catheter, Ultrasound Equipment, Interventional Devices, Generator。

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