First-in-India: Johnson & Johnson Receives Approval for VARIPULSE™ Platform, Advancing Atrial Fibrillation Treatment

BusinessWire India
Mumbai (Maharashtra) [India], June 3: 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:
-84.2% freedom from documented atrial arrhythmia recurrence at 12 months,4 based on Kaplan-Meier estimates.xxviii
-A strong safety profile with 0.8% primary adverse event (PAE) rate and zero reported strokes, coronary spasm or other PFA-related complications. xxviii,5
-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."
Note: 'First in India' claim is based solely on the chronology of regulatory approval/registration granted by the applicable Indian regulatory authority.
* The local legal entity in India is Johnson & Johnson Private Limited
1. When compared to procedures that did not use navigation systems.
2. As of May 2026
3. Based on a subset of 29 deep sedation patients from the inspIRE study and 60 patients in inpsIRE study. Procedures completed under sedation vs general anesthesia had comparable safety rates and procedure times, demonstrating safety and procedural efficiency.
4. Freedom from documented (symptomatic and asymptomatic) atrial arrythmia recurrence with episodes >=30 seconds recorded by ECG after a 3-month blanking period
5. Patients without at least 90 days of follow-up are excluded from the safety evaluation unless they experienced a PAE
6. All safety events were assessed up to 90 days, as available
7. Dr. Lakkireddy serves as a consultant for Johnson & Johnson but was not compensated for this announcement
The VARIPULSE™ Platform
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.
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.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to the VARIPULSETM Platform. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
General Disclaimer:
The VARIPULSE™ Platform is a medical device and should be used only by appropriately trained healthcare professionals in accordance with the approved indications, applicable labelling, and instructions for use in India. This press release is intended solely for informational purposes and should not be construed as medical advice, a solicitation to patients, or a substitute for the independent clinical judgment of a qualified healthcare professional. Individual patient outcomes may vary, and treatment decisions should be made by the treating physician based on the patient's clinical condition and applicable medical guidance.
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