Bangalore, June 3: Johnson & Johnson MedTech Announces India Approval of VARIPULSE Platform, a First-of-its-Kind Pulsed Field Ablation Technology for Atrial Fibrillation
Johnson & Johnson today announced the approval in India of the VARIPULSE Platform, the country’s first Pulsed Field Ablation (PFA) technology for the treatment of atrial fibrillation . The platform has already been used globally in more than 80,000 procedures.
Atrial fibrillation is an irregular and often rapid heartbeat caused by disorganized electrical signals in the atria. It is associated with structural changes in the heart and significantly increases the risk of stroke, heart failure, and mortality.
Globally, AFib affects an estimated 50 million people, while heart failure impacts over 64 million individuals. In India, prevalence is estimated between 0.1% and 1.6% of the population, with nearly 5 million people currently living with the condition. Notably, Indian patients tend to develop AFib nearly a decade earlier than their Western counterparts, at an average age of around 55 years. In many cases, AFib is only detected after a stroke occurs, accounting for 20–45% of stroke cases in India.
Stroke remains a major public health concern, with India reporting approximately 773,000 stroke deaths in 2021, representing 10% of global stroke mortality.
Catheter ablation is a minimally invasive procedure that restores normal heart rhythm by targeting abnormal electrical pathways in the heart. Pulsed Field Ablation (PFA) is an advanced form of ablation that uses short, high-voltage electrical pulses to selectively affect cardiac cells, offering a potentially safer and more efficient treatment option for AFib.
The VARIPULSE™ Platform integrates ablation and mapping within a single workflow when used with the CARTO™ 3 System, a 3D electroanatomical cardiac mapping technology. This enables real-time visualization, improved precision, and enhanced procedural efficiency for physicians treating AFib patients. The system is designed to support minimal to no fluoroscopy exposure and is compatible with both deep and conscious sedation approaches.
Speaking on the development, Randeep Sharma, General Manager, India, Electrophysiology, MedTech, Johnson & Johnson, said:
“The approval of the VARIPULSE™ Platform in India marks an important milestone in advancing AFib treatment. Pulsed field ablation is gaining momentum globally, and bringing an integrated platform like VARIPULSE™ to India will enable physicians to deliver more precise and efficient care for AFib patients.”
Clinical evidence supporting the platform continues to grow. The VARIPURE real-world dataset from Europe reported 84.2% freedom from atrial arrhythmia recurrence at 12 months, along with a 0.8% primary adverse event rate and no reported strokes or PFA-related complications. Similarly, the Real AF registry in North America demonstrated a 0.6% adverse event rate, zero reported strokes, and 86.5% same-day discharge rates.
Commenting on the innovation, Dr. Dhanunjaya Lakkireddy, Executive Medical Director and Professor of Medicine at the Kansas City Heart Rhythm Institute, said:
“Pulsed Field Ablation is a rapidly emerging technology that can revolutionize arrhythmia care in India. Its adoption will require continued clinical evaluation and training to ensure safe and effective use. Integration with 3D mapping empowers specialists with advanced therapeutic tools that can significantly improve patient outcomes.”
The introduction of the VARIPULSE Platform marks a significant step forward in advancing electrophysiology care in India and expanding access to next-generation treatment options for atrial fibrillation.
