Clinical Trial to Evaluate Medtronic Cryoablation as First-Line Treatment for Patients With Symptomatic Paroxysmal Atrial Fib...
July 11 2017 - 10:00AM
DUBLIN - July 11, 2017 -
Medtronic plc (NYSE: MDT) today announced first enrollments in
the STOP AF First clinical trial. The trial will evaluate the
safety and effectiveness of performing pulmonary vein isolation
(PVI) with the Arctic Front Advance(TM) Cryoballoon in patients
with symptomatic paroxysmal atrial fibrillation (AF) prior to
treatment with antiarrhythmic medications. The first patient in the
trial was recently enrolled at The Ohio State University Wexner
Medical Center by Jaret Tyler, M.D.
STOP AF First is a prospective, interventional,
multicenter, randomized, controlled, clinical trial that will
enroll up to 210 patients at up to 30 sites in the United States.
Patients will be randomized to cryoballoon ablation (treatment arm)
or antiarrhythmic drug (AAD) therapy (control arm), and followed
for 12 months. Oussama Wazni, M.D., co-director of Atrial
Fibrillation Center at Cleveland Clinic, serves as the study's
national principal investigator.
"Clinical research shows that about half of
patients with symptomatic AF do not respond to antiarrhythmic
drugs, leading to recurrence," said Colleen Fowler, vice president
and general manager of the AF Solutions business, part of the
Cardiac and Vascular Group at Medtronic. "As AF progresses, it
becomes more difficult to treat, and has lower long-term success
rates. With the number of AF patients expected to increase
exponentially in the coming years, this trial will help ascertain
whether earlier treatment with the cryoballoon can improve outcomes
for a greater number of patients."
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 (freezing) rather than heat (radiofrequency) to create
scar tissue and interrupt irregular electrical pathways in the
heart.
The 2016 European Society of Cardiology's (ESC)
guidelines and the recent 2017 Heart Rhythm Society (HRS) Consensus
Statement for the management of atrial fibrillation both
acknowledge cryoablation therapy as an appropriate ablation energy
for treating AF, and recognize PVI as an effective and preferred
treatment option for select patients with AF.
In the U.S., first-line treatment of symptomatic
paroxysmal AF with the Arctic Front Advance Cryoablation System is
investigational use only; the system is approved in the U.S. for
the treatment of drug refractory, recurrent, symptomatic paroxysmal
AF, and in Europe for the treatment of atrial fibrillation. More
than 250,000 patients in more than 50 countries worldwide have been
treated with the cryoballoon.
More than 33 million people worldwide have
AF,1 including
nearly 6.1 million adults in the United States,2 a
number expected to double in the next 25 years.3 Representing
a quarter of all AF patient cases,4 paroxysmal
AF occurs when the rapid rhythm in the heart's upper chambers start
and stop suddenly, usually for minutes or days at a
time.5
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 91,000 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 January C,
Wann L, Alpert J, Calkins H, et al. 2014 AHA/ACC/HRS guideline for
the management of patients with atrial fibrillation: a report of
the American College of Cardiology/American Heart Association Task
Force on Practice Guidelines and the Heart Rhythm Society. J Am
Coll Cardiol. 2014.
3 Go A, Hylek
E, Phillips K, et al. Prevalence of Diagnosed Atrial Fibrillation
in Adults: National Implications for Rhythm Management and Stroke
Prevention: the AnTicoagulation and Risk Factors In Atrial
Fibrillation (ATRIA) Study. JAMA. 2001; 285(18): 2370-2375.
4 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.
5 Medtronic,
plc. (n.d.). ABOUT ATRIAL FIBRILLATION. Retrieved from
http://www.medtronic.com/us-en/patients/conditions/atrial-fibrillation-afib.html.
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
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 Aug 2024 to Sep 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Sep 2023 to Sep 2024