Medtronic Technologies Improve Delivery of Cardiac Resynchronization Therapy
August 29 2016 - 9:00AM
First-of-its-Kind
Data on EffectivCRT(TM) for Heart
Failure Patients with Atrial Fibrillation Presented at ESC
DUBLIN and ROME - Aug. 29, 2016
- Medtronic plc (NYSE:MDT) today announced results from the
Cardiac Resynchronization Therapy Efficacy Enhancement (CRTee)
study. The study showed that the Medtronic-exclusive device-based
EffectivCRT(TM) during AF
algorithm improves therapy delivery in heart failure patients with
atrial fibrillation (AF). The results were presented at the 2016
European Society of Cardiology (ESC) Congress in Rome.
Current CRT devices report "percent pacing" - a
measure of whether the device sends a pacing pulse to stimulate the
heart. However, current devices do not report the effectiveness of
each pacing stimulus - that is, whether the pacing pulse "captures"
the heart muscle and improves its pumping ability.
The new EffectivCRT during AF feature
automatically determines the effectiveness of each left ventricular
pace and adjusts pacing rates during AF. This is important for
heart failure patients suffering from AF, because the pacing pulse
from the device is more likely to be ineffective or interrupted
because of this irregular heart rhythm.
"This technology brings us one step closer to
understanding effective left ventricular pacing for AF patients
receiving CRT, which has been difficult to manage in the past" said
Suneet Mittal, M.D., director, Electrophysiology Laboratory,
Arrhythmia Institute of the Valley Health System, Ridgewood, NJ.
"We can now optimize treatment to a larger patient base, including
difficult-to-treat non-responders, to hopefully prevent patients
from undergoing additional treatments and often invasive follow-on
procedures."
The EffectivCRT Diagnostic and EffectivCRT during
AF algorithm are available on the Claria MRI(TM) Quad CRT-D
SureScan(TM) in Europe. The EffectivCRT features
are investigational only in the United States; the Claria CRT-D is
not approved for sale in the U.S. The Claria device, which is
approved for full-body MRI scans in 1.5 and 3T machines, can be
paired with Attain Performa(TM) quadripolar lead technology. In
addition to the new EffectivCRT features, the Claria device
includes the Medtronic-exclusive AdaptivCRT(TM) algorithm,
which has been shown to provide a 46 percent reduction in AF
risk1 and reduce a
patient's odds of a 30-day heart failure readmission by 59
percent2.
CRTee was a prospective, randomized, crossover
study of 71 patients with paroxysmal, persistent or permanent AF.
Sixty-six patients were randomized first to either an existing
algorithm or the new EffectivCRT algorithm, with the desired
outcome of a higher percent of effective CRT being delivered during
AF. Fifty-four patients completed both arms. The EffectivCRT group
increased effective pacing during AF by 7 percent, from 81 percent
to 88 percent, p<0.001. Heart rate increased by only three
beats-per-minute, from 77 to 80 BPM, p<0.001. Patients with a
low percent of pacing at baseline (less than or equal to 80
percent) received the greatest benefit (average absolute increase
of 15 percent effective pacing).
"Medtronic has made great strides in providing
patients with a range of products that incorporate the most
advanced technology available to improve CRT response," 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. "We are continually expanding
our research and development to create better solutions for
improved outcomes, based on individualized care in cardiac rhythm
and heart failure devices."
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 Martin
DO, et al. Clinical Outcomes with Adaptive Cardiac
Resynchronization Therapy: Long-Term Outcomes of the Adaptive CRT
Trial. HFSA Late Breakers. September 23,
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.
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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