Johnson & Johnson Unveils Breakthrough PFA Platform Data at HRS 2025: 100% Acute PVI Success, 0% Neurovascular Events

Johnson & Johnson Announces Three Studies at HRS2025, Featuring Its Three Key PFA Products, IncludingOmnypulse、VARIPULSE andDual-Energy THERMOCOOL SMARTTOUCH SF Catheter. Three studies respectively demonstrate the superior safety, effectiveness, ease of use, and predictability of three PFA products.

• Omnypulse：100% Acute Success Rate

• VARIPULSE：0% Neurovascular Events

• Dual-Energy THERMOCOOL SMARTTOUCH SF Catheter: 92% of cases with prediction error ≤ ±1mm

Executive Evaluation

"Our PFA product portfolio is built around the core clinical needs—long-lasting efficacy, operational controllability, safety, and efficiency. The data from Omny-IRE, VARIPURE, and the dual-energy catheter demonstrate our commitment to providing safe, effective, and reliable PFA tools."

---Jennifer Currin  Vice President of Scientific Affairs, Johnson & Johnson Medical Technology

Currently, Johnson & Johnson has launched two PFA products (VARIPULSE andDual-Energy THERMOCOOL SMARTTOUCH SF Catheter,Omnypulse is progressing rapidly and will soon be available to patients. Among themVARIPULSE has been launched in three mainstream markets: China, the United States, and the European Union. RecentlyVARIPULSE has already completed the first round of commercial applications for patients in dozens of hospitals in China, with very rapid commercial progress. This also showcases the strong electrophysiology foundation of Johnson & Johnson.

At the same time, real-world studies in Europe have also shownVARIPULSE High Safety:0% neurovascular events. This marks the complete resolution of the safety issues that troubled doctors and patients at the end of the year.VARIPULSE can also quickly provide new treatment options for atrial fibrillation patients in the market according to the normal progress.

AndThe high efficacy and dual-energy predictability of the Omnypulse THERMOCOOL SMARTTOUCH SF catheter also provide Johnson & Johnson with stronger firepower in its subsequent competition with Boston Scientific, Medtronic, and Abbott.

【01】Omnypulse

Specific Research Results

• 100% Success Rate of Pulmonary Vein Isolation in Acute PhaseThree months later, the electrophysiological retest of the pulmonary veins showed that 84.5% of the pulmonary veins remained persistently isolated.

• The incidence of major adverse events was only 3.0%., among which potential catheter-related events accounted for only 0.7%.

OmnypulsePlatformByOmnypulseCatheter, Johnson & Johnson General Energy Generator TRUPULSE andCARTO 3Composition.

• OmnypulseCatheter: The world's first 12mm large curved-tip Pulse Field Ablation (PFA) catheter, equipped with contact force sensing and TRUEref reference electrode, can reduce far-field unipolar signal interference;

• TRUPULSE Energy Generator: Provide biphasic bipolar pulse output for the catheter's 12 electrodes

• CARTO 3: Generate PF index values through real-time contact force feedback and the number of pulse field applications to guide precise ablation.

PI Evaluation

"Three-month data demonstrates the early potential of the Omnypulse platform—100% acute success rate and 84.5% durable isolation rate, combined with an extremely low safety event rate, confirming the platform's clinical value in achieving repeatable and durable outcomes through integration with the CARTO™3 system."

---Mattias Duytschaever  AZ Sint-Jan Hospital

【02】VARIPULSE

Johnson & Johnson's VARIPURE Study Evaluates Real-World Safety and Operator Learning Curve of the VARIPULSE Platform in Pulmonary Vein Isolation (PVI) for Atrial Fibrillation. This prospective post-market study, conducted across 13 centers in Europe, enrolled 247 patients (currently over 600 patients have been enrolled and enrollment is ongoing) and involved 40 operators with varying levels of experience (including first-time users). Key findings include:

• Zero Serious Adverse Events:No Neurovascular EventsOr complications such as coronary artery spasm

• Quick Start Capability: Among the operators who completed the first 10 surgeries, no significant learning curve was observed except for a slight reduction in idle time during the ablation interval; treatment outcomes were stable for 115 patients.
  PI Evaluation

"VARIPULSE Platform Combines Excellent Safety with User-Friendliness for New Users, Achieving Safe and Stable Treatment Outcomes from the First Surgery. As PFA Technology Becomes More Widespread, This Platform is Expected to Promote the Broad Implementation of Safe and Efficient Ablation Procedures."

---Francis Bessière  Hôpital Cardiologique Louis Pradel

【03】Dual-Energy THERMOCOOL SMARTTOUCH SF Catheter

Hiroshi Nakagawa announced preclinical research data, which verified the PF index predictive efficacy of the dual-energy THERMOCOOL SMARTTOUCH SF catheter through a porcine heart beating model:

• Accurate Prediction of Ablation Depth: 92% of cases with prediction errors ≤ ±1mm, 100% of cases ≤ ±1.5mm

• Dynamic Dosing Guidance: The PF index integrates the number of pulses and the logarithmic calculation of contact force to provide the operator with real-time ablation depth parameters.
  Note: This index, after optimization, supports the formation of persistent damage, significantly enhancing surgical predictability and clinical precision.