Medtronic Challenges Johnson & Johnson for Leadership in the $10B+ Electrophysiology Market

Recently, Medtronic announced a head-to-head clinical study (SPHERE Per-AF) on electrophysiology products at the HRS 2024 conference.Dual-energy Ablation Catheter and 3D Mapping System:Medtronic's Sphere-9 + Affera, Johnson & Johnson's Thermocoll SmartTouchSF + Carto 3,The results showed that Medtronic outperformed Johnson & Johnson.

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 experimental group was treated with Medtronic Sphere-9+Affera catheter, while the control group was treated with Johnson & Johnson Thermocoll SmartTouchSF+Carto 3 catheter.In this trial, participants were randomized in a 1:1 ratio, with a total of 420 patients recruited across 23 centers in the United States, the Czech Republic, and Israel.

What does this head-to-head clinical study mean? This requires a discussion of the market positions of the two products involved.

First, the Medtronic Sphere-9 Dual-Energy Ablation Catheter + Affera 3D Mapping System are bothMedtronic acquired Affera for $925 million in early 2022.Affera Prism-1 Cardiac Mapping and Navigation Platform, when used in conjunction with the Sphere-9 catheter, enables electrophysiologists (EP) to rapidly create detailed electroanatomical maps for diagnosing arrhythmias and delivering cardiac ablation therapy.

Take the Sphere-9 Dual-Energy Ablation Catheter,This means that Medtronic possesses three technologies: electric pulse, radiofrequency, and mapping, which also perfectly compensates for its weakness in the PFA field.

Sphere-9 can achieve one-time pulmonary vein isolation through its compressible lattice sphere at the tip, while also offering the flexibility of point-by-point ablation. In the global PFA field,In addition to Medtronic's self-developed and marketed PulseSelect,Only Boston Scientific's Farapulse PFA product has been approved by the FDA,The unique technological advantages of Sphere-9 have enabled Medtronic to kick off a rapid advancement in the global PFA race.

AndAcquiring the Affera Prism-1 3D mapping system fills the gap for Medtronic, which previously lacked mapping and navigation technology. This head-to-head trial also signals its attempt to disrupt the market as a latecomer.After all, electrophysiology giants Johnson & Johnson, Abbott, and Boston Scientific all have their own 3D mapping and navigation technologies.

In contrast, the control group of this trial, Johnson & Johnson's Thermocoll SmartTouch SF+Carto 3, has always been a benchmark in the field of radiofrequency ablation for atrial fibrillation.Especially, Carto 3 is the cornerstone for Johnson & Johnson to maintain its dominance in the electrophysiology ablation field.

Carto 3 is Johnson & Johnson's most advanced three-dimensional mapping system, which also holds an absolute dominant position among the eight three-dimensional mapping systems available globally.Its core advantage lies in the system's rich functionality modules, which can integrate multiple mapping catheters to achieve different objectives.

Especially in the Chinese market, 2020Johnson & Johnson's 3D mapping system holds a 65% market share.Abbott's market share is only 27%, and Carto 3's status in the 3D mapping field is evident.

Johnson & Johnson's Thermocool SmartTouch SF dual-energy catheter can switch between radiofrequency and pulsed field.The first clinical study was just completed this April, and the results showed that the acute success rate of the dual-energy ablation catheter was 100%.

It is widely believed in the industry that,This product is a response to Medtronic's acquisition of Affera and the Sphere-9 takeover.As of yesterday (May 23), Medtronic disclosed in its annual report for the fiscal year 2024,Affera Sphere-9 Ablation Catheter Has Been Submitted to FDA,Awaiting approval.

It is not difficult to see that Medtronic and Johnson & Johnson have long begun their secret competition.This head-to-head clinical study (SPHERE Per-AF) undoubtedly places both parties in direct competition.Medtronic's superior trial results over Johnson & Johnson have, to a certain extent, shaken Johnson & Johnson's absolute dominance in the 3D mapping field, also signaling Medtronic's determination to disrupt the competitive market landscape.Meeting at the Summit: The Competition Between the Two Sides in the PFA Pulsed Field Ablation Field Has Thus Begun.

Last year, the CEO of Medtronic stated,In the future, its business focus will be on five high-growth areas, one of which is cardiac electrophysiology.

Why does Medtronic place such importance on the cardiac electrophysiology sector?

As the third major track in the field of cardiovascular interventional treatment devices, cardiac electrophysiology has enormous market potential. With"Catheter Ablation Technology"The latest breakthrough has led Wall Street analysts in the U.S. to believe that the existing landscape of the global cardiac electrophysiology market may undergo significant changes. Meanwhile,"Catheter ablation" is one of the fields with the most "moderate" price reductions in China's centralized procurement, retaining some room.Conducive to the further development of China's cardiac electrophysiology market.

Medtronic's Strategic Layout in the Cardiovascular Field,Medtronic has embarked on an aggressive catch-up campaign characterized by major acquisitions and the approval of multiple new products.

Thus far,Medtronic has completed a comprehensive layout in the two core tracks of electrophysiology —— 3D mapping and ablation.At the same time, it further strengthens its grasp of core technologies in this field through acquisitions, building its own moat.

But overall, in 2023, the three giants in the electrophysiology field,Johnson & Johnson, Abbott, and Medtronic's business revenue reached 4.688 billion USD, 2.195 billion USD, and 800 million USD respectively.As a latecomer, the gap in market share between Medtronic and the top two giants remains significant, and whether it can overtake them is still uncertain.

The field of cardiac electrophysiology (catheter ablation) involvesMapping, AblationTwo major technologies. This is where Medtronic and Johnson & Johnson confront each other in direct competition.

Cardiac mapping is widely used for the identification and localization of arrhythmias. Mapping methods are divided into two-dimensional and three-dimensional. Compared with two-dimensional,The main advantages of 3D surgery are low radiation, high surgical safety, and a short learning curve for doctors.

Based on the significant advantages of 3D mapping, globally, 3D electrophysiology procedures have completely replaced 2D as of now.Surgical volume accounts for over 80%.

In the field of 3D mapping, the mainstream players are Johnson & Johnson's CARTO® 3 system and Abbott's EnSite system.

Currently, in the 3D mapping market in China, Johnson & Johnson and Abbott products together account for more than 90% of the market share, while domestically produced 3D mapping systems are still in the initial stage.Minimally Invasive Electrophysiology and Huitai Medical successively launched their own magnetic and electric fusion three-dimensional mapping systems.Fills the gap in domestically produced magnetoelectric fusion 3D mapping systems, marking the beginning of domestic substitution in the 3D mapping field.

Medtronic Acquires Affera, Takes Over Affera Prism-1 3D Mapping System, Outperforms Johnson & Johnson in Head-to-Head Trials, Poised to Further Shake Up the Global and Chinese Market Landscape.

Following radiofrequency ablation and cryoablation,Pulsed Field Ablation (PFA) is considered the next-generation ablation technology in the electrophysiology field and is expected to become the mainstream in the market.

PFA has advantages over traditional radiofrequency ablation and cryoablation technologies, such as tissue selectivity and non-thermal ablation. During surgical treatment, PFA does not cause damage to adjacent nerves, blood vessels, smooth muscles, or other myocardial tissues. Additionally, PFA offers advantages such as lower operational difficulty, ease of use, high ablation efficiency, and time savings.

According to the current data trend analysis, pulsed field ablation (PFA) technology is expected to achieve significant popularity and application worldwide in the near future, particularly showcasing its unique advantages in the field of catheter ablation for atrial fibrillation.

According to industry experts' predictions,In the next approximately five years, PFA technology is expected to occupy a significant position in the global electrophysiology treatment market, with its market share projected to reach between 30% and 50%.This prediction highlights the potential and value of PFA technology in the field of cardiac electrophysiology treatment.

Currently, in terms of the approval of giant PFA products, Boston Scientific, Johnson & Johnson, and Medtronic each hold a position, forming a tripartite situation. Additionally, Abbott has also started to catch up.

And shifting the focus back to the Chinese market, at the end of last year, Jinjiang Electronics' LEAD-PFA Cardiac Pulse Field Ablation System and PulsedFA Single-Use Cardiac Pulse Field Ablation Catheter received NMPA marketing approval, achieving a significant leap forward.Becoming the first PFA product approved for marketing in China.

In addition, currently in China, at least 50 companies are developing PFA cardiac ablation systems. The PFA products from companies such as Denovo Electrophysiology, Huitai Medical, Xuanyu Medical, and Yuanshan Medical have already entered the special review process of the National Medical Products Administration (NMPA).

It can be said that in the PFA track, Johnson & Johnson, Abbott, Medtronic, and Boston Scientific, the international giants, are making comprehensive efforts, while domestically-produced alternatives are accelerating to catch up.Almost at the same starting line.

Medtronic, which obtained the world's first certification in the PFA field, continues to advance.Step upAcquisition; In the field of 3D mapping, Medtronic has overtaken Johnson & Johnson to make great strides forward. However, the global electrophysiology market has become increasingly competitive. Whether Medtronic can disrupt the market landscape and achieve dual breakthroughs in technology and performance in the electrophysiology sector remains to be answered over time.