Johnson & Johnson has announced the approval of the VARIPULSE™ Platform, a Pulsed Field Ablation (PFA) technology in India for catheter ablation procedures in patients with atrial fibrillation (AFib). According to the company, the platform has been used in more than 80,000 catheter ablation procedures globally.
Atrial fibrillation is an irregular and often rapid heartbeat caused by extra, uncoordinated electrical signals in the atria. The condition is associated with structural changes in the heart arising from underlying conditions and lifestyle factors. It is linked to an increased risk of stroke, heart failure and mortality.
According to the company, atrial fibrillation affects 50 million people worldwide. In India, the prevalence of AFib is estimated to range between 0.1 per cent and 1.6 per cent of the population, with around 5 million people currently living with the condition.
The company stated that Indian patients develop AFib at an average age of around 55 years, nearly a decade earlier than patients in Western populations. It also noted that underlying AFib is detected at the time of stroke in 20–45 per cent of cases in India.
Johnson & Johnson stated that early intervention is important in managing AFib and reducing stroke risk. According to the company, India accounted for 773,000 stroke deaths in 2021, representing 10 per cent 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. Pulsed Field Ablation is a catheter ablation technique that uses short, high-voltage electrical pulses to target cardiac cells by creating pores in cell membranes, resulting in cell death.
According to the company, the VARIPULSE™ Platform is designed to integrate ablation and mapping into a single workflow through the CARTO™ 3 System. The system uses 3D electroanatomical cardiac mapping technology to provide real-time visualisation and support physicians treating patients with atrial fibrillation.
Johnson & Johnson stated that the platform supports precision, efficiency, reproducibility and procedural accuracy. The company added that the system enables therapy with minimal to no fluoroscopy exposure and is compatible with deep and/or conscious sedation.