Mumbai, Maharashtra, India – Approval introduces Pulsed Field Ablation technology to India. The VARIPULSE™ Platform is the first Pulsed Field Ablation system fully integrated with the CARTO™ 3 electroanatomical mapping system, designed to drive efficiency, reproducibility, and procedural accuracy.1, i, ii, iii, iv, v, vi, vii, viii, ix
Johnson & Johnson* today announced the approval of the VARIPULSE™ Platform, India’s first Pulsed Field Ablation (PFA) technology that has been used to perform catheter ablation procedures for atrial fibrillation (AFib) in more than 80,000 procedures globally.2 AFib is an irregular and often rapid heartbeat caused by extra, uncoordinated electrical signals in the atria and 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.
Atrial Fibrillation affects 50 million people worldwide,xii representing a burden comparable to heart failure, which impacts over 64 million people globally.xiii In India, AFib prevalence is estimated at 0.1% to 1.6% of the population, with approximately 5 million people currently living with the condition.xiv, xv, xvi Indian patients develop AFib nearly a decade earlier than those in Western populations, at an average age of around 55 years, extending the long-term disease burden.xvii, xviii Underlying AFib in India is detected at the time of stroke in 20–45% of cases.xix As a progressive condition, early intervention in AFib is critical to reducing stroke risk, particularly given that India accounted for 773,000 stroke deaths in 2021, or 10% of global stroke deaths.xx
