Surgical Robotics Technology
Johnson & Johnson MedTech announced the launch of the VARIPULSE™ Platform in Asia-Pacific. The platform is used to perform catheter ablation procedures for atrial fibrillation (AFib), an irregular and often rapid heartbeat caused by extra, uncoordinated electrical signals in the atria.x AFib is associated with structural changes in the heart due to underlying conditions and lifestyle factors.x,xi It significantly increases the risk of stroke, heart failure, and mortality.
The VARIPULSE™ Platform is the first PFA technology designed to streamline ablation and mapping through a single integrated workflow with the CARTO™ 3 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 (AFib)xii. It enables safe and efficienti,ii,iii,iv,v,vi,vii, patient-centric therapy with minimal to no fluoroscopy exposurexiii,xiv,xv and is compatible with deep and/or conscious sedation.2,xvi,xvii
This innovation is backed by compelling clinical evidence. Both the inspIRE and admIRE clinical trials demonstrated strong safety and effectiveness of the VARIPULSE™ Platform:
- In inspIRE, 80% of patients achieved freedom from recurrence with zero primary adverse events.xviii
- In admIRE, results showed a 75% overall primary effectiveness success rate3, a 2.9% primary adverse event rate4,xix, 100% of patients achieved acute procedural success5, 43% had same-day discharge, and 25% of procedures were performed without fluoroscopy6.
- In the ongoing VARIPURE registry, which included first-time users, there were no serious adverse events and no complications linked to the platform, including zero neurovascular events or coronary spasmsxx.
“The introduction of the VARIPULSE™ Platform in the Asia-Pacific region marks a significant advancement towards our goal of transforming atrial fibrillation care,” stated Jing Li, Vice President, Electrophysiology & Neurovascular, Johnson & Johnson MedTech, 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.”
Atrial Fibrillation affects over 16 million people in Asia-Pacificxxi. Symptoms and clinical consequences of AFib disrupt patient’s quality of life. The most common symptoms are heart palpitations, fatigue, shortness of breath, chest pain, and dizzinessxxii. As a progressive condition, early intervention is critical to reducing the risk of stroke, heart failure, and cardiovascular mortalityxxiii.
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.
“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” said Dr. Yasuo Okumura7, Professor and Department Head, Vice Hospital Director, Nihon University School of Medicine, Itabashi Hospital, Tokyo, Japan. “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.”
Source: Johnson & Johnson
