Medtronic Receives FDA Expanded Approval for Arctic Front™ Family of Cardiac Cryoablation Catheters for Initial Use for Recurrent Symptomatic Paroxysmal Atrial Fibrillation
- First and Only Approval to Indicate Cryoablation as an Initial Rhythm Control Strategy
- Offers Safe, Effective Alternative to Antiarrhythmic Drug Therapy for the Prevention of Atrial Arrythmia Recurrence
Nearly 60 million people worldwide1 are affected by atrial fibrillation (AF). AF is a progressive disease, meaning over time patients can experience more frequent, and longer episodes, and medication as well as catheter ablation can become less effective. Additionally, AF is associated with serious complications including heart failure, stroke and increased risk of death2-5.
Managing AF can be a lifelong burden for patients, and AAD therapy has been the current standard first-line treatment. However, AAD therapy is ineffective at controlling AF in approximately half of patients treated with drug therapy6-8 and AAD usage frequently causes side effects that can lead many to discontinue treatment.9 Only after experiencing AAD failure, do some patients then go on to receive a catheter ablation.
"Expanded FDA approval, coupled with the growing body of clinical evidence, demonstrate cryoablation as a first-line treatment is a more effective solution for preventing atrial arrhythmia recurrence," said
STOP AF First
, a Medtronic-sponsored, prospective, multicenter, randomized trial, included 225 patients at 24 sites in the
U.S.Patients who had never received AAD therapy were randomized to cryoablation or AAD treatment and followed for 12 months. Results, published in the New England Journal of Medicine(NEJM) in Nov. 2020, reported 74.6% of patients in the cryoballoon versus 45.0% in the AAD group (P<0.001) achieved treatment success at 12 months. The quality of life (QoL) data published in NEJM demonstrate that cryoballoon ablation resulted in significant improvements in quality of life as assessed using the Atrial Fibrillation Effect on Quality-of-Life [AFEQT] and European Quality of Life–5 Dimensions [EQ-5D] questionnaires. A low rate of patient complications occurred when using catheter ablation as a first-line treatment (12-month rate of primary safety events: 1.9%), and the percentage of patients with a serious adverse event was similar between the treatment groups.
, an investigator-initiated, multicenter trial, randomized 303 patients with AF who had never received AAD to cryoballoon-based pulmonary vein isolation or first-line AAD therapy. Results from EARLY-AF, published in the
New England Journal of Medicine(NEJM) in Nov. 2020and presented at American Heart Association Scientific Sessions 2020, found 57.1% of patients in the cryoballoon versus 32.2% in the AAD group achieved freedom from atrial tachyarrhythmia recurrence at 12 months. Mean AF burden was lower in the cryoballoon (0.6±3.3%) vs. AAD group (3.9±12.4%). Patients treated with cryoablation demonstrated larger improvements in quality of life and more frequently had resolution of arrhythmic symptoms (e.g., fatigue, rapid heartbeat, shortness of breath) than patients receiving AAD therapy. Safety events were low in both groups with 3.2% of catheter ablation and 4.0% of AAD-treated patients experiencing a serious adverse event related to the trial regimen.
, a Medtronic-sponsored, randomized, multicenter trial, enrolled 220 patients at 18 sites in nine countries across
Europe, Australiaand Latin America. At 12 months, freedom from atrial arrhythmia recurrence was achieved in 82.2% of the cryoballoon and 67.6% of the AAD group. Cryo-FIRST demonstrated that more patients with PAF who received first-line treatment with Medtronic cryoablation vs. AAD therapy were asymptomatic at 12 months. Cryoablation resulted in significant improvement in in AF-specific health-related quality of life at 12 months compared to AAD therapy. The cryoablation and AAD arms had comparable safety profiles in terms of the rate of serious adverse events.
"With this milestone announcement, Medtronic now has the only ablation catheter approved by the FDA to be used a as first-line treatment in the
The FDA recently expanded the indication for Medtronic cryoablation therapy to include treating patients with drug refractory recurrent symptomatic paroxysmal and persistent atrial fibrillation (episode duration less than 6 months) as well as the treatment of recurrent symptomatic paroxysmal atrial fibrillation as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. Medtronic has pioneered cryoablation technology, with an industry-leading and extensive body of evidence, including proven safety and efficacy in treating AF. To date, nearly one million patients have been treated with the Medtronic cryoablation therapy worldwide.
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. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the
- 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.
- 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.
- 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 J2020.
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
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 Assoc2013;2:e000126
- Wazni OM, Dandamudi G, Sood N, et al. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med.
January 28, 2021;384(4):316-324.
- Kuniss M, Pavlovic N, Velagic V, et al. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. Europace.
March 17, 2021:euab029.
- Andrade JG, Wells GA, Deyell MW, et al. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med.
January 28, 2021;384(4):305-315.
- Valembois L et al. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database of Systematic Reviews 2019, Issue 9. Art. No.: CD005049. DOI: 10.1002/14651858.CD005049.pub5.
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