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Johnson & Johnson has 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.
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. It significantly increases the risk of stroke, heart failure, and mortality.
Atrial Fibrillation affects 50 million people worldwide, representing a burden comparable to heart failure, which impacts over 64 million people globally.
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. 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.
Underlying AFib in India is detected at the time of stroke in 20–45% of cases. 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.
Catheter ablation is a minimally invasive procedure used to restore normal heart rhythm by treating areas responsible for abnormal electrical signals. PFA is a catheter ablation technique that uses short, high-voltage electrical pulses to target cardiac cells by creating pores in cell membranes, leading to cell death. It has the potential to offer safe, consistent, and efficient therapy for AFib treatment.
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). It enables safe and efficient, patient-centric therapy with minimal to no fluoroscopy exposure and is compatible with deep and/or conscious sedation.