Medtronic Receives FDA Approval for Claria MRI(TM) Quad Cardiac Resynchronization Therapy Defibrillator
November 14 2016 - 9:15AM
First CRT-D in
U.S. to Help Improve Therapy
Delivery
in Heart Failure Patients Using Effective
Pacing
DUBLIN - Nov. 14, 2016
- Medtronic plc (NYSE:MDT) has received U.S. Food and Drug
Administration (FDA) approval for the Claria MRI(TM) Quad
Cardiac Resynchronization Therapy Defibrillator (CRT-D)
SureScan(TM) device for patients with heart failure. The Claria MRI
CRT-D is approved for scanning in both 1.5 and 3 Tesla (T) magnetic
resonance imaging (MRI) machines, and features EffectivCRT(TM), a
new algorithm that automatically tailors the therapy to individual
patients by adjusting pacing rates.
"Until now, CRT devices have shown only whether a
pacing pulse was sent, but we haven't been able to determine if
that stimulation actually improves the heart's pumping ability,"
said Suneet Mittal, M.D., director, Electrophysiology Laboratory,
Arrhythmia Institute of the Valley Health System, Ridgewood, N.J.
"With the Claria device, physicians are now able to verify the
effectiveness of left ventricular pacing, which is especially
beneficial for improving outcomes in patients with atrial
fibrillation, who have been difficult to treat because this
irregular and rapid heartbeat often interferes with the delivery of
effective CRT."
A large percentage of heart failure patients
receiving cardiac resynchronization therapy have atrial
fibrillation (AF),1 which can
significantly reduce patient response to CRT. The Claria device
includes the Medtronic-exclusive EffectivCRT Diagnostic, which
automatically determines the effectiveness of each left ventricular
pace, and the EffectivCRT during AF algorithm, which automatically
adjusts pacing rates during AF, without adversely affecting the
average heart rate.
Additional features on the Claria device
include:
-
The 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
- VectorExpress(TM) 2.0,
an automated in-office test that reduces lead programing to
two minutes,4 and
reveals clinically actionable information to help physicians select
optimal pacing configurations for each patient.
- Attain(TM) Perfoma(TM) MRI
SureScan(TM) Quadripolar Leads, which include short
bipolar spacing to reduce phrenic nerve stimulation
occurrence,5 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 (ICDs), insertable cardiac monitors
(ICMs) and CRT-Ds. Additionally, patients with certain existing
defibrillation leads will be eligible for an MR-conditional ICD or
CRT-D, and thus able to access this important imaging
technology.
"The Claria MRI CRT-D is our latest innovation to
help improve patients' response to CRT, establishing a new level of
personalized care," 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.
"And it further expands our industry-leading MR-conditional
portfolio of devices, which are helping to improve the lives of
more patients throughout the world."
In addition to introducing CRT to the worldwide
marketplace nearly 20 years ago, and offering the first
MR-conditional CRT-defibrillators in the U.S., the Medtronic heart
failure portfolio includes mechanical circulatory support therapy
and impactful heart failure diagnostics and expert analysis through
Medtronic Care Management Services.
Medtronic also has submitted a Pre-Market
Application (PMA) to the FDA for Multiple Point Pacing, which, if
approved, would be available with the Claria MRI and Amplia MRI(TM)
CRT-Ds. The Multiple Point Pacing feature is not
currently approved for commercial sale in the United
States.
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 Kloosterman
M, Maass AH, Rienstra M, Van Gelder IC. Atrial fibrillation during
cardiac resynchronization therapy. Card
Electrophysiol Clin. December 2015;7(4):735-748.
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 Demmer, W.
VectorExpress performance results. Medtronic data on file. January
2013.
5 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
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Source: Medtronic plc via Globenewswire
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