Johnson & Johnson MedTech has received regulatory approval in India for the VARIPULSE™ Platform, introducing Pulsed Field Ablation (PFA) technology to support the treatment of atrial fibrillation (AFib), one of the most common cardiac rhythm disorders worldwide. The approval makes the platform available to physicians treating patients with AFib, a condition characterized by irregular electrical activity in the heart that can increase the risk of stroke, heart failure, and other cardiovascular complications. Globally, atrial fibrillation affects an estimated 50 million people, while approximately five million individuals in India are believed to be living with the condition.
The VARIPULSE Platform combines ablation and cardiac mapping technologies within a single integrated workflow. The system includes the VARIPULSE catheter, TRUPULSE generator, and the CARTO 3 mapping platform, enabling physicians to visualize cardiac anatomy and electrical activity in real time during procedures.
Pulsed Field Ablation is a catheter-based treatment that uses short-duration electrical pulses to selectively target cardiac tissue responsible for abnormal heart rhythms. The technology is designed to improve procedural precision while reducing exposure to surrounding structures. The platform also supports treatment approaches that may require little or no fluoroscopy and can be used with different sedation strategies depending on clinical requirements.
Johnson & Johnson stated that the approval is supported by clinical and real-world evidence from international studies involving the platform. Data from the VARIPURE registry in Europe demonstrated strong effectiveness and a favorable safety profile over a 12-month period. Additional findings from the Real AF registry in the United States and Canada reported low adverse event rates and high rates of same-day patient discharge following procedures.
Randeep Sharma, General Manager, Electrophysiology, India, Johnson & Johnson MedTech, said the approval represents an important advancement for cardiac rhythm management in India. He noted that growing adoption of Pulsed Field Ablation worldwide reflects increasing confidence in the technology among physicians treating atrial fibrillation.
Dr Dhanunjaya Lakkireddy, Executive Medical Director and Professor of Medicine at the Kansas City Heart Rhythm Institute, highlighted the significance of introducing advanced ablation technologies in a country where AFib is often diagnosed late and contributes substantially to stroke-related health burdens.
The introduction of the VARIPULSE Platform adds a new treatment option for electrophysiologists in India and reflects ongoing advances in minimally invasive cardiovascular care aimed at improving patient outcomes and procedural efficiency.At Johnson & Johnson, we are committed to advancing health and improving lives through innovation. By harnessing our deep expertise across Innovative Medicine and MedTech, we work to address some of the world’s most pressing healthcare challenges.
Our goal is to help prevent, treat, and cure complex diseases while developing smarter, less invasive, and more personalized healthcare solutions. Through continuous scientific advancement and a patient-focused approach, we are shaping the future of healthcare and delivering meaningful breakthroughs that create a lasting impact on people and communities around the world.
