Johnson & Johnson Launches VARIPULSE™ Pulsed Field Ablation Platform Across Asia-Pacific for Atrial Fibrillation Treatment
核心洞察
Johnson & Johnson MedTech (搜索) has launched the VARIPULSE™ Platform (搜索) across Asia-Pacific, marking the first Pulsed Field Ablation system fully integrated with CARTO™ 3 (搜索) electroanatomical mapping for atrial fibrillation (搜索) treatment.
Clinical trials demonstrated strong efficacy with 80% of patients achieving freedom from recurrence in inspIRE and 75% overall primary effectiveness success rate in admIRE.
The platform addresses a significant unmet need for over 16 million people affected by atrial fibrillation (搜索) in Asia-Pacific, offering potentially safer ablation with minimal fluoroscopy exposure.
Johnson & Johnson MedTech (搜索) announced the launch of the VARIPULSE™ Platform (搜索) across Asia-Pacific, introducing the first Pulsed Field Ablation (PFA) system fully integrated with the CARTO™ 3 (搜索) electroanatomical mapping system for treating atrial fibrillation (搜索) (AFib). The platform is approved in Japan, Hong Kong, China, Australia, Taiwan and Korea, addressing a condition that affects over 16 million people in the Asia-Pacific region.
Revolutionary Integration Technology
The VARIPULSE™ Platform (搜索) represents a significant advancement in cardiac arrhythmia treatment by streamlining ablation and mapping through a single integrated workflow with the CARTO™ 3 (搜索) System. This 3D electroanatomical cardiac mapping technology enables real-time visualization and supports precision, efficiency, reproducibility, and procedural accuracy for physicians treating patients with atrial fibrillation (搜索).
The platform enables safe and efficient, patient-centric therapy with minimal to no fluoroscopy exposure and is compatible with deep and/or conscious sedation. Unlike traditional ablation methods that use heat or cold, PFA uses short bursts of energy to affect heart tissue, potentially reducing the risk of damage to surrounding tissue such as the esophagus, pulmonary veins, and phrenic nerve.
Strong Clinical Evidence
The innovation is backed by compelling clinical evidence from multiple trials. In the inspIRE clinical trial, 80% of patients achieved freedom from recurrence with zero primary adverse events. The admIRE trial demonstrated a 75% overall primary effectiveness success rate, a 2.9% primary adverse event rate, with 100% of patients achieving acute procedural success. Additionally, 43% had same-day discharge, and 25% of procedures were performed without fluoroscopy.
The ongoing VARIPURE registry, which included first-time users, showed no serious adverse events and no complications linked to the platform, including zero neurovascular events or coronary spasms.
Addressing Critical Medical Need
Atrial fibrillation (搜索) is an irregular and often rapid heartbeat caused by extra, uncoordinated electrical signals in the atria, associated with structural changes in the heart due to underlying conditions and lifestyle factors. It significantly increases the risk of stroke (搜索), heart failure (搜索), and mortality. The most common symptoms are heart palpitations, fatigue, shortness of breath, chest pain, and dizziness, which disrupt patients' quality of life.
"The introduction of the VARIPULSE™ Platform (搜索) in the Asia-Pacific region marks a significant advancement towards our goal of transforming atrial fibrillation (搜索) care," stated Jing Li, Vice President, Electrophysiology & Neurovascular, Johnson & Johnson MedTech (搜索), Asia Pacific. "The adoption of the VARIPULSE™ Platform could demonstrate the unique value of integration with CARTO™ 3D to enhance efficiencies in the workflow of AFib treatment and improve patient outcomes."
Expert Perspective on PFA Technology
Dr. Yasuo Okumura, Professor and Department Head, Vice Hospital Director, Nihon University School of Medicine, Itabashi Hospital, Tokyo, Japan, emphasized the potential of this new technology: "PFA, as a new type of energy, has the potential to further enhance the safety and efficacy of catheter ablation treatment, which is desirable for patients. PFA is a relatively new medical technology, and therefore it is important to continue to assess its effectiveness and efficacy in Asia while ensuring proper use. But so far, we know that the integration of PFA technology with 3D mapping enables physicians to review their procedure in detail, and this contributes to quality of healthcare for patients."
Platform Components and Global Approval
The VARIPULSE™ Platform (搜索) is Johnson & Johnson MedTech (搜索)'s comprehensive Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator (搜索), and CARTO™ 3 (搜索) Mapping System VARIPULSE™ Software. The Platform is now approved for use in the United States, Europe, Asia Pacific, and Canada.
As a progressive condition, early intervention is critical to reducing the risk of stroke (搜索), heart failure (搜索), and cardiovascular mortality, making the availability of this advanced technology particularly significant for the Asia-Pacific region's large patient population.