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]
Chennai: 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]
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.[xxi]
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).[xxii] It enables safe and efficient,i,ii,iii,iv,v,vi,vii patient-centric therapy with minimal to no fluoroscopy exposure[xxiii],[xxiv],[xxv] and is compatible with deep and/or conscious sedation.[3],[xxvi],[xxvii]
“The approval of the VARIPULSE™ Platform in India marks an important milestone in advancing AFib treatment,” said Randeep Sharma, General Manager, India, Electrophysiology, MedTech, Johnson & Johnson. “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.”
The innovation is backed by compelling clinical evidence with the most recent real-world evidence demonstrating strong safety and effectiveness of the VARIPULSE™ Platform:
- VARIPURE– the largest prospective real-world dataset for the VARIPULSE™ Platform in Europe–reported a favorable 12-month interim effectiveness, including:
- Real AF– an observational, prospective, multicenter registry in US and Canada designed to obtain real-world clinical experience using the VARIPULSE Platform–reported:[xxix]
- A strong safety profile with a 0.6% primary adverse event rate and zero reported strokes, coronary spasm, or other PFA-related complications.[6]
- 86.5% same day discharge.
“In India, where the disease burden is significant, access to care is complex, continued innovation in treatment approaches is especially relevant.” said Dr. Dhanunjaya Lakkireddy, Executive Medical Director and Professor of medicine at the Kansas City Heart Rhythm Institute,[7] “Pulsed Field Ablation is a rapidly emerging technology, that can revolutionize arrhythmia care in India as it did with the rest of the world. Its adoption in India will require continued clinical evaluation and appropriate training to ensure safe and effective use. Integration of PFA technology with 3D mapping empowers heart rhythm specialists with superior therapeutic tools that can significantly improve quality of healthcare for patients.”
The VARIPULSE™ Platform is Johnson & Johnson MedTech’s Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Software.
Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit biosensewebster.com.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn.
