- 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
DUBLIN, June 21, 2021 /PRNewswire/ -- Medtronic plc
(NYSE: MDT), the global leader in medical technology, today
announced it received U.S. Food and Drug Administration (FDA)
expanded approval 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. The expanded
indication is based on results from STOP AF First, a prospective,
multicenter randomized study that demonstrated superior efficacy of
the Medtronic cryoablation procedure for preventing atrial
arrhythmia recurrence compared to the use of AAD therapy.
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 Oussama
Wazni, M.D., section head, Electrophysiology, Cardiovascular
Medicine, Cleveland Clinic and principle investigator for the STOP
AF First clinical trial. "With this new indication, physicians now
have more options to treat AF earlier, and we've seen that
patients do better when treated earlier. Patients can now be
referred for a cryoablation to effectively control their
AF rather than trying drug therapy first, potentially allowing
them get back to living their lives without the added anxiety of
progressing AF symptoms and potential health
complications."
The Medtronic Arctic Front family of Cardiac Cryoablation
Catheters are the first and only catheter ablation devices in the
U.S. approved to help physicians improve AF patient outcomes before
drug failure, and shorten the time from diagnosis to ablation with
effective, efficient, and predictable
outcomes.6 Three recent clinical trials showed the
safety of the Medtronic cryoballoon and demonstrated the
superiority of Arctic Front Cryoballoon ablation for preventing
atrial arrhythmia recurrence in patients with paroxysmal AF (PAF)
who have not failed AAD therapy.6-8
- STOP AF First6, 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.
- EARLY-AF8, 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. 2020 and 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.
- Cryo-FIRST7, a Medtronic-sponsored,
randomized, multicenter trial, enrolled 220 patients at 18
sites in nine countries across Europe, Australia and 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 U.S. to treat AF. The indication expansion
demonstrates how Medtronic continues to lead the way in cardiac
ablation solutions for arrhythmia management and fill a market need
for an early rhythm control strategy for what is an very
progressive disease," said Rebecca
Seidel, president of the Cardiac Ablation Solutions
business, which is part of the Cardiovascular Portfolio at
Medtronic. "For the millions of Americans who struggle with simple,
daily tasks like walking up the stairs or getting the mail because
of their AF, the expanded indication offers an alternative
treatment option to antiarrhythmic drug therapy."
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.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services and
solutions companies – alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
- 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 J 2020.
- 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 Assoc 2013;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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