DUBLIN and BARCELONA, Spain -
MARCH 19, 2018 - Medtronic plc (NYSE: MDT) today announced
one-year results from the CRYO4PERSISTENT AF study of ablation with
the Arctic Front Advance(TM) Cryoballoon to isolate the pulmonary
veins in patients with symptomatic persistent atrial fibrillation
(AF). The Arctic Front Advance Cyroablation System is not approved
for treating persistent AF in the United States.
The study results, presented today at the European
Heart Rhythm Association (EHRA) Scientific Sessions 2018 in
Barcelona, Spain, showed 60.7 percent of persistent AF patients
were free from all atrial arrhythmias (adjudicated AF, atrial
flutter or atrial tachyarrhythmias) lasting more than 30 seconds,
at one year following a single ablation procedure. These clinically
meaningful results are on par with outcomes seen in the FIRE AND
ICE trial of paroxysmal AF patients (approximately 70 percent at 12
months), and are encouraging given these patients are in a more
advanced disease state.
The study findings also demonstrated short and
predictable procedure times of 53 ±22 minutes with the cryoballoon
and a low device- and/or procedure-related complication rate of 4
percent.
"The findings demonstrate the benefits of
cryoablation therapy in reducing the significant burden patients
experience once AF progresses, and hold promise for physicians to
realize efficient procedure times and a low rate of adverse events
for their persistent AF patients," said Serge Boveda, M.D.,
co-director of the Cardiac Arrhythmias Department in Clinique
Pasteur, Toulouse, France, and co-principal investigator in the
trial. "These results are encouraging and demonstrate the
reproducibility of the cryoballoon procedure even in patients with
persistent AF."
Medtronic is a world leader in the diagnosis,
management and treatment of AF. AF is one of the most common heart
rhythm disorders, affecting more than 33 million people
worldwide.1 In
Europe and the United States, AF affects approximately 10 and 5
million people respectively. In both geographies, persistent AF
represents approximately a quarter of all AF cases.2,3 Persistent
AF occurs when the upper chambers of a patient's heart beat
erratically for more than seven days and procedural intervention
and/or drug therapy are required to stop the episode and restore
normal sinus rhythm. Additionally, the risk of stroke and heart
failure increases in patients with AF.4,5
"This is the first study of its kind to closely
observe patients with persistent AF using a PVI-only strategy with
the cryoballoon," said Pascal Defaye, M.D., Arrhythmia Unit,
Department of Cardiology, Grenoble-Alpes University Hospital,
Grenoble, France, and co-principal investigator in the trial. "The
results are noteworthy and provide valuable insights for the
physician community."
Cryoballoon ablation is used in a minimally
invasive procedure to isolate the pulmonary veins, which are a
source of erratic electrical signals that cause AF. The device uses
cold energy rather than heat (radiofrequency (RF) ablation) to
create scar tissue and interrupt irregular electrical pathways in
the heart. Recent studies have shown comparable safety and
effectiveness when using cryoballoon ablation compared to RF
ablation when treating symptomatic paroxysmal AF patients, as well
as shorter and more consistent procedure times.6,7
"Similar to what we saw with the FIRE AND ICE
clinical trial, the CRYO4PERSISTENT AF findings demonstrate the
significant benefits of cryo energy for the treatment of AF," said
Rebecca Seidel, vice president and general manager of the AF
Solutions business, part of the Cardiac and Vascular Group at
Medtronic. "As more and more physicians around the world adopt
cryoablation, we are committed to providing the technology and
expertise to help them bring better, more efficient care for their
patients."
More than 370,000 patients in more than 60
countries worldwide have been treated with the cryoballoon. The
Arctic Front Advance Cryoablation System is approved in Europe for
the treatment of AF. In the U.S., the Arctic Front Advance
Cryoablation System is approved for the treatment of drug
refractory, recurrent, symptomatic paroxysmal AF.
The 2016 European Society of Cardiology's (ESC)
guidelines and the 2017 Heart Rhythm Society (HRS) Consensus
Statement for the management of AF both acknowledge cryoablation
therapy as a reasonable ablation energy for treating AF and
recognize PVI as an effective and preferred treatment option for
select patients with AF.
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. Medtronic 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 CRYO4PERSISTENT
AF
CRYO4PERSISTENT AF is a prospective, single-arm, interventional,
multi center, non-randomized clinical trial that evaluated the
12-month clinical outcomes of cryoballoon ablation for isolating
pulmonary veins, without additional ablation strategies, using the
Medtronic Arctic Front Advance Cryoballoon System to treat patients
with persistent AF. Eligible patients were defined as having
documented symptomatic persistent AF at baseline lasting longer
than 7 days and up to 180 days. Prior to procedure, enrolled
patients were monitored using 18-hour Holter recorders to ensure
all investigated patients met the 100 percent persistent AF
documentation criteria. Per protocol, a total of 101 patients were
analyzed and followed for 12 months at 11 medical centers
throughout Europe. Co-principal investigators are Dr. Serge Boveda
and Dr. Pascal Defaye.
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 84,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 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.
-end-
1 Chugh S,
Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial
fibrillation: a global burden of disease 2010 study. Circulation.
2014; 129:837-847.
2 Zoni-Berisso
M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial
fibrillation: European perspective. Clinical Epidemiology.
2014;6:213-220. doi:10.2147/CLEP.S47385.
3 Mozaffarian
D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke
Statistics-2016 Update: A Report From the American Heart
Association. Circulation. 2016 Jan 26;133(4):e38-360
4 Fuster
et al. Journal of the American College of Cardiology. 2006;
48:854-906.
5 ACC/AHA/ESC
Guidelines for the Management of Patients with Atrial
Fibrillation
6 Ciconte,
G., Baltogiannis, G., Asmundis, C. D., et al. Circumferential
pulmonary vein isolation as index procedure for persistent atrial
fibrillation: a comparison between radiofrequency catheter ablation
and second-generation cryoballoon ablation. Europace. 2015; 17(4),
559-565. doi:10.1093/europace/euu350.
7 Kuck, K.H.,
Brugada J, Furnkranz A, et al., Cryoballoon or Radiofrequency
Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med, 2016.
374(23): p. 2235-45.
Contacts:
Becky Bousquet
Public Relations
+1-763-514-0114
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2024 to May 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From May 2023 to May 2024