- First patient in India treated at Max Hospital, Saket
- Nearly 60 million people worldwide are affected by atrial fibrillation1
India Medtronic Private Limited, a wholly owned subsidiary of Medtronic plc (NYSE:MDT) — a global leader in healthcare technology, today announced the launch of Arctic Front™ Cardiac Cryoablation Catheter System, the first and only cryoballoon catheter approved by CDSCO for treatment of atrial fibrillation (AF) in India. Dr. Balbir Singh, chairman of Cardiology, Pan Max Hospital Saket, Delhi, successfully performed the first procedure in India using the Arctic Front™ Cardiac Cryoablation Catheter System. Cryoballoon catheter ablation, a minimally invasive procedure, is one of the therapeutic modalities to manage AF.
Nearly 60 million people worldwide are affected by AF.1 AF is an irregular heart rhythm that affects the upper chambers (atria) of the heart. A normal heart beats around 60-100 times per minute. However, in AF, the atria quiver instead of beating normally. AF can also lead to rapid heart rhythm, where the heart can beat as much as 300 times a minute or more in the atria and up to 150 times a minute or more in the lower chambers (ventricles). Additionally, AF is associated with serious complications including heart failure, stroke and increased risk of death.2-5 Indian patients with AF tend to be over a decade younger than AF patients in the western world, and two-thirds of them have either persistent or permanent AF.6 Indian AF patients also tend to have higher rates of death compared to other countries.6,7
“AF is a progressive disease, meaning over time patients can experience more frequent, and longer episodes. Cryoballoon ablation is a safe and effective treatment before or after medication therapy to control atrial fibrillation,” said Dr. Singh. “By treating patients with the most advanced, clinically relevant technology, we are better equipped to successfully manage their atrial fibrillation, thereby improving their overall quality of life.”
“Cryoballoon ablation is a minimally invasive procedure that offers a short recovery time and comparable safety and efficacy to standard radiofrequency therapy, but with the benefit of greater treatment efficiency. In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias,” said Madan Krishnan, vice president and managing director, Medtronic India.
Cryoablation is designed to prevent unwanted electrical signals from traveling from the pulmonary veins (large blood vessels that carry blood from the lungs to the left atrium of the heart) and spreading to the atria (the upper chambers of the heart). This is done with a technique known as pulmonary vein isolation that targets the tissue where the veins and the atria connect and prevents the spread of unwanted electrical signals. The Medtronic cryoballoon catheter was developed specifically to achieve pulmonary vein isolation. This innovative technique has been used to treat more than 1,000,000 patients in more than 80 countries with robust safety and effectiveness evidence in more than 1200 peer-reviewed articles.8
During June of this year, Medtronic received U.S. Food and Drug Administration (FDA) expanded approval in the United States for the Arctic Front™ Family of Cardiac Cryoablation Catheters for the treatment of recurrent symptomatic paroxysmal atrial fibrillation (episodes that last less than seven continuous days) as an alternative to antiarrhythmic drug (AAD) therapy as an initial rhythm control strategy. This new indication expansion should help physicians treat AF patients earlier in the disease progression stage, which may enhance the therapeutic effectiveness.
1 Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
2 Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
3 Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
4 Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
5 Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126.
6 Vora A, Kapoor A, Nair M, et al. Clinical presentation, management, and outcomes in the Indian heart Rhythm Society-Atrial Fibrillation (IHRS-AF) registry. Indian Heart J 2017;69:43 – 47.
7 Sawhney JP, Kothiwale VA, Bisne V, et al. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry. Indian Heart J 2018;70(6):828-835.
8 Status: June 2020, Medtronic Data on File [Instruction for use 2017 Medtronic, M970045A001 1A, 2017-10-05. Arctic Front™ Cardiac Cryoablation Catheter System, already CE marked for AF ablation in EMEA, is now the first FDA approved catheter system for paroxysmal and persistent AF ablation in the US].