Medtronic Exclusive Reactive ATP(TM) Therapy Slows Progression of Atrial Fibrillation in Real-World Patient Population
June 18 2017 - 9:00AM
Data Presented as
Late Breaking Clinical Trial at EUROPACE 2017
DUBLIN and VIENNA - June 18, 2017
- Continuing its leadership in the detection, reduction, and
treatment of atrial fibrillation (AF), Medtronic plc (NYSE: MDT)
today announced that its Reactive ATP(TM) therapy slows the
progression of AF in patients with implanted cardiac devices. A
robust, real-world analysis of nearly 8,800 patients was presented
as a late breaking clinical trial at EHRA EUROPACE-CARDIOSTIM
2017.
An unusually fast or quivering rhythm in the
heart's upper chambers (atria), AF is a progressive disease that
afflicts more than 33 million people worldwide.1 Common
among patients with cardiac devices, AF impairs quality of life,
and increases the risk of hospitalization, stroke and death.
Reactive ATP (atrial-based antitachycardia pacing) is an advanced,
painless pacing therapy found exclusively on Medtronic pacemakers,
implantable cardioverter defibrillators (ICDs) and cardiac
resynchronization therapy (CRT) devices. It repeatedly sends pacing
pulses to the atria during abnormally fast rhythms to restore the
heart's normal rhythm, thereby slowing the progression of AF.
The retrospective analysis assessed pacemaker, ICD
and CRT device data from 8,798 patients followed by the Medtronic
CareLink® remote monitoring system. Reactive ATP therapy was
associated with a statistically significant decrease in AF events
compared to a matched control group. Most notably, the Reactive ATP
patient group experienced a 38 percent reduction in persistent AF
events (lasting greater than seven days) (p<0.0001). This
benefit was observed across patient age, sex, and device type.
"Atrial fibrillation can be a debilitating disease
that imposes a significant burden upon the entire healthcare
community - impacting patients, caregivers, providers and costs of
care - especially as the disease progresses," said Giuseppe
Boriani, M.D., Ph.D., full professor of cardiology at the
University of Modena and Reggio Emilia, Italy. "These are the first
real-world data on the clinical impact of Reactive ATP therapy and
the first in patients with ICDs and CRT devices. These data have
important implications for all device patients because of the high
prevalence of AF and the correlation of disease progression to
worsened patient outcomes."
This study builds upon the MINERVA trial, the
first randomized, controlled study of Reactive ATP. It found that
Reactive ATP therapy significantly slowed AF disease progression in
patients with pacemakers with the therapy, compared to those
without it.2 Furthermore,
Reactive ATP significantly reduced AF-related hospitalizations,
emergency department visits and cardioversions, resulting in payer
cost savings.2,3
"Physicians have been asking how the CareLink
Network data can be leveraged to gain real-world insights into the
benefits of our therapies," said Rob Kowal, M.D., Ph.D., vice
president and chief medical officer of the Cardiac Rhythm and Heart
Failure Division at Medtronic. "This study does exactly that. It
helps us understand how Reactive ATP impacts the burden of
persistent atrial fibrillation in a larger and more varied group of
patients than we might normally be able to study within the
constraints of a controlled trial."
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 88,000 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 Padeletti,
L., Pürerfellner, H., Mont, L. et al. New-generation atrial
antitachycardia pacing (Reactive ATP) is associated with reduced
risk of persistent or permanent atrial fibrillation in patients
with bradycardia: Results from the MINERVA randomized multicenter
international trial. Heart Rhythm. 2015;12:1717-1725.
3 Boriani G,
Manolis AS, Tukkie R et al. Effects of enhanced pacing modalities
on health care resource utilization and costs in bradycardia
patients: An analysis of the randomized MINERVA trial. Heart Rhythm
2015;12:1192-200.
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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