Medtronic Receives CE Mark for Its Next Generation Cardiac Resynchronization Therapy-Pacemakers
February 24 2017 - 8:00AM
Suite of Smart
Heart Failure Devices Offers More-Effective Pacing, Expanded MRI
Access
DUBLIN - Feb. 24, 2017 -
Medtronic plc (NYSE:MDT) today announced that it has received CE
(Conformité Européenne) Mark for a suite of
quadripolar cardiac resynchronization therapy pacemakers (CRT-Ps)
that also allow patients to receive MRI (magnetic resonance
imaging) scans in either 1.5 or 3 Tesla (T) machines. This complete
line of CRT-Ps, available in Europe in March, includes the
Percepta(TM) Quad CRT-P
MRI SureScan(TM),
Serena(TM) Quad CRT-P
MRI SureScan(TM) and
Solara(TM) Quad CRT-P
MRI SureScan(TM), and
enables proactive heart failure management alongside
industry-leading pacing technology and patient access to the most
advanced diagnostic imaging procedures available. These devices are not yet approved for sale in the United
States.
"Quadripolar devices, such as these new
pacemakers, allow more pacing programming options, which allows us
to better optimize CRT delivery," said Dr. Massimo Mantica of
Istituto Clinica Sant'Ambrogio, Milano, Italy. "Advanced technology
continues to give us smarter devices that enable more personalized
treatment for patients."
The Percepta Quad CRT-P features the
EffectivCRT(TM)
Diagnostic, which automatically determines the effectiveness of
each left ventricular pace, and the EffectivCRT(TM)
during AF algorithm, which automatically adjusts pacing rates
during atrial fibrillation (AF), without adversely affecting the
average heart rate. It also includes VectorExpress(TM) 2.0, an
automated in-office test that reduces lead programing to two
minutes,1 and
reveals clinically actionable information to help physicians select
optimal pacing configurations for each patient.
The Percepta Quad and Serena Quad CRT-Ps also
feature the Medtronic-exclusive AdaptivCRT(TM) algorithm,
which reduces a patient's odds of a 30-day heart failure
readmission by 59 percent,2 and has
demonstrated a 46 percent reduction in AF risk compared to
echo-optimized biventricular pacing.3 Both devices
also feature Multiple Point Pacing, which can stimulate two sites
on the left ventricle (lower chamber) simultaneously or
sequentially.
Additional features available in all three devices
include:
- Attain(TM) Perfoma(TM) MRI
SureScan(TM) Quadripolar Leads, which include short
bipolar spacing to reduce phrenic nerve stimulation
occurrence,4 steroid on
all electrodes, and three shapes for varying patient
anatomies.
- SureScan(TM) MR-conditional
labeling for full-body scans without positioning restrictions.
Medtronic now offers MR-conditional pacemakers, implantable
cardioverter defibrillators, insertable cardiac monitors, cardiac
resynchronization therapy defibrillators (CRT-Ds) and CRT-Ps.
"With the addition of quadripolar CRT-P devices to
our heart failure portfolio, we now offer a comprehensive line of
CRT devices to further meet the needs of patients throughout
Europe," said David Steinhaus, M.D., vice president and general
manager of the Heart Failure business, and medical director for the
Cardiac Rhythm and Heart Failure division of Medtronic. "Our new
quadripolar CRT-P devices include advanced, smart technologies that
allow physicians to provide each patient with the appropriate
therapy specific to his or her individual needs, all while offering
access to advanced life-saving MRI technologies."
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 Demmer, W.
VectorExpress performance results. Medtronic data on file. January
2013.
2 Starling
RC, Krum H, Bril S, et al. Impact of a Novel Adaptive Optimization
Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT
Trial. JACC Heart Fail. July
2015;3(7):565-572.
3 Martin D, et
al. Clinical outcomes with adaptive cardiac resynchronization
therapy: Long-term outcomes of the Adaptive CRT Trial. HFSA Annual
Scientific Meeting. September 23,
2013.
4 Biffi et al.
Effort of bipolar electrode spacing on phrenic nerve stimulation
and left ventricular pacing thresholds: An acute canine study.
Circulation Arrhythmia and Electrophysiology.
2012.
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
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