Medtronic Receives FDA Approval for New Single-Chamber ICDs That Detect Atrial Fibrillation
02 May 2016 - 11:00PM
Visia AF
MRI(TM)
SureScan®
and Visia AF(TM)ICDs
Treat Dangerous Heart Rhythms and Enable Physicians to Identify
Patients at Increased Risk for Stroke and Heart Failure Due to
AF
DUBLIN - May 2, 2016 -
Medtronic plc (NYSE: MDT) today announced it has received U.S. Food
and Drug Administration (FDA) approval for the Visia AF
MRI(TM)
SureScan® and Visia
AF(TM)
single-chamber implantable cardioverter defibrillators (ICDs). The
Visia AF devices can detect previously undiagnosed and/or
asymptomatic atrial fibrillation (AF) and monitor recurrent AF,
while treating life-threatening rhythms in the lower chambers of
the heart. The Visia AF ICD systems will be commercially available
in early summer.
AF is a condition that involves an irregular
quivering or rapid heart rhythm in the upper chambers (atria) of
the heart. Because many patients do not experience symptoms, the
condition frequently goes undetected, even with traditional
external monitors1-2. When left
untreated, patients with AF are five times more likely to have a
stroke3 and three
times more likely to develop heart failure4.
The Visia AF ICDs include a proprietary algorithm
that detects AF episodes (without a lead in the atrium) and
captures AF frequency and duration, information that helps
physicians identify AF and tailor treatment for these patients.
More than half of all new ICD implants in the U.S. are
single-chamber devices.
"Approximately 75 percent of ICD patients have no
history of atrial fibrillation at the time they receive a device,"
said Edward J. Schloss, MD, director of cardiac electrophysiology,
The Christ Hospital, Cincinnati. "After device implant, we've seen
about 20 percent of these patients go on to have newly discovered
AF. Until now, we haven't been able to detect these arrhythmias
with single chamber ICD diagnostics. The Visia AF ICDs give
physicians a new tool to monitor for AF in patients with VR ICDs,
which may allow them to identify and treat AF earlier to
potentially help avoid other serious conditions."
Built on the proven performance of the Medtronic
Evera(TM) family of ICDs, the Visia AF ICDs include:
- SureScan® Labeling: Approved
for MRI scans on any part of the body without positioning
restrictions, as well as for MRI scans in 1.5 Tesla (magnet
strength) machines
- Physio Curve® Design: A
contoured shape with thin, smooth edges that increases patient
comfort by reducing skin pressure by 30 percent5
- Greater Battery Longevity:
Industry-leading battery longevity (up to 11 years)6-13
- Sprint Quattro(TM) Leads:
Paired with the Sprint Quattro(TM) family of
leads, the most frequently prescribed lead, with more than 10
years of proven performance with active monitoring14
- SmartShock(TM)
2.0: An exclusive shock reduction algorithm that enables the
device to better differentiate between dangerous and harmless heart
rhythms,15 delivering a
98 percent inappropriate shock-free rate at one year16
In addition, remote monitoring through the
Medtronic CareLink® Network is
available with the Visia AF ICDs, connecting patients to their
clinics from home or away.
"Early detection of AF is vital to assist
physicians in making treatment decisions that can reduce stroke and
heart failure risk," said John Liddicoat, M.D., senior vice
president, Medtronic, and president of the Cardiac Rhythm and Heart
Failure division. "These single chamber defibrillators with AF
detection capabilities, utilizing our proven Quattro lead -
alongside our overall portfolio of AF detection devices -
demonstrate our commitment to providing cardiac patients with the
latest technology to improve their health."
The Visia AF ICDs received CE Mark in 2015. This
FDA approval further expands the Medtronic portfolio of
MR-conditional cardiac rhythm and heart failure devices, which
includes MR-conditional pacemakers, ICDs, insertable cardiac
monitors (ICMs) and cardiac resynchronization therapy
defibrillators (CRT-Ds).
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
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 85,000 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 Strickberger
SA, Ip J, Saksena S, et al. Relationship between atrial
tachyarrhythmias and symptoms. Heart Rhythm.
2005;2:125-31.
2 Ziegler
PD, Koehler JL, Mehra R. Comparison of continuous versus
intermittent monitoring of atrial arrhythmias. Heart Rhythm.
2006;3:1445-52.
3 Wolff
PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent
risk factor for stroke the Framingham Study. Stroke. 1991;22 (8): 983-988.
4 Stewart
S, Hart CL, Hole DJ, et al. A population-based study of the
long-term risks assocated with atrial fibrillation: 20-year
follow-up of the Renfrew/Paisey Study. Am J
Med. October 1, 2002; 113 (5):359-364.
5 Flo,
Daniel. Device Shape Analysis. January 2013. Medtronic data
on file.
6 Knops P,
Theuns DA, Res JC, et al. Analysis of implantable defibrillator
longevity under clinical circumstances: implications for device
selection. Pacing Clin Electrophysiol. October
2009;32(10):1276-1285.
7 Schaer
BA, Koller MT, Sticherling C, et al. Longevity of implantable
cardioverter defibrillators, influencing factors, and comparison to
industry-projected longevity. Heart Rhythm. December
2009;6(12):1737-1743.
8 Biffi M,
Ziacchi M, Bertini M, et al. Longevity of implantable
cardioverter-defibrillators: implications for clinical practice and
health care systems. Europace. November
2008;10(12):1288-1295.
9 Kallinen
L, et al. 2009.
http://spo.escardio.org/eslides/view.aspx?eevtid=33&id=1913.
10 Thijssen
J, Borleffs CJ, van Rees JB, et al. Implantable
cardioverter-defibrillator longevity under clinical circumstances:
an analysis according to device type, generation, and manufacturer.
Heart Rhythm. April 2012;9(4):513-519.
11 Shafat
T, Baumfeld Y, Novack V, et al. Significant differences in the
expected versus observed longevity of implantable cardioverter
defibrillators (ICDs). Clin Res Cardiol.
Published online July 14, 2012.
12 Horlbeck
FW, Mellert F, Kreuz J, et al. Real-world data on the lifespan of
implantable cardioverter-defibrillators depending on manufacturers
and the amount of ventricular pacing. J Cardiovasc
Electrophysiol. December 2012;23(12):1336-1342.
13 Visia
AF/Visia AF MRI Manuals.
14 Medtronic
Product Performance Report, 2012 Second Edition, Issue
66.
15 Volosin
KJ, Exner DV, Wathen MS, et al, Combining shock reduction
strategies to enhance ICD therapy: a role for computer modeling. J
Cardiovasc Electrophysiol. 2011 Mar;22(3):280-9.
16 Auricchio
A, Schloss EJ, Kurita T, et al. Low inappropriate shock rates in
patients with single and dual/triple chamber ICDs using a novel
suite of detection algorithms: PainFree SST Trial Primary Results.
Heart Rhythm. 2015 May;12(5):926-36.
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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