New Study Shows Promise in Treating More Patients with World’s Smallest Pacemaker
November 11 2019 - 9:00AM
Medtronic plc (NYSE:MDT) today announced results from the
MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer)
study showing that an investigational set of algorithms in the
Micra™ Transcatheter Pacing System (TPS) significantly
improves synchrony and cardiac function in patients with
impaired electrical conduction between the chambers of the heart,
called atrioventricular (AV) block. The results from the
MARVEL 2 study will be presented Nov. 16 during a Featured Science
session at American Heart Association 2019, the AHA Scientific
Sessions and were published today in JACC: Clinical
Electrophysiology.
Based on positive results from both the MARVEL and
MARVEL 2 studies, Medtronic submitted a new leadless pacemaker,
Micra AV, to expand the indicated population to AV block and
normal sinus rhythm. This submission is currently under FDA
review. The Micra AV submission is not approved and the product is
not currently available for sale in the United States. By
federal law, Micra AV is investigational use only.
“While leadless pacing has many advantages
compared to traditional pacemakers - including fewer
infection-related complications - leadless pacemakers are currently
only capable of single-chamber ventricular sensing and pacing,”
said Larry Chinitz, M.D., MARVEL 2 study co-principal investigator,
cardiac electrophysiologist and director of NYU Langone’s Heart
Rhythm Center in New York City. “Our investigation shows that
accelerometer-based atrial-sensing algorithms can sense signals
from the atrium in the heart and make calculated adjustments to
when ventricular pacing occurs, thus improving coordination between
the atrium and ventricle. These results provide further evidence
that these novel investigational algorithms added to the Micra TPS
may allow more patients, including those with normal sinus rhythm
and AV block, to benefit from a leadless pacemaker.”
The MARVEL 2 study evaluated 75 patients with a
Micra TPS at 12 centers in Hong Kong, Malaysia, Europe and the
United States. Investigators evaluated the safety and effectiveness
of accelerometer-based atrial sensing algorithms, which were
downloaded to the Micra TPS device. Forty patients had complete
heart block and normal sinus rhythm and were eligible for inclusion
in the primary efficacy analysis while all 75 patients were
included in the primary safety objective. Investigators evaluated
the ability of the Micra accelerometer to monitor and detect atrial
contractions and enable coordinated pacing between the atrium and
ventricle, thereby providing AV synchrony.
Using continuous device telemetry and
an electrocardiogram Holter monitor, patients’ AV synchrony
was measured during 20 minutes of rest and
during single-chamber ventricular (VVI) pacing. The
study’s primary efficacy objective was met, with a significantly
greater percentage of complete heart block patients with normal
sinus rhythm having >70% AV synchrony during
algorithm-mediated AV synchronous pacing (38 of 40 patients, 95%)
than VVI pacing (0 patients, P<0.001 for proportion of patients
with >70% synchrony). The median percent AV synchrony was
94.3% during AV synchronous pacing compared to 26.9% during VVI
pacing.
In addition, blood flow from the left ventricle
(velocity time integral, a proxy for stroke volume), increased by
1.7 cm (on an absolute scale, 95% CI: 0.7-2.7cm, P=0.002; or 8.8%
on a relative scale) during AV synchronous pacing compared with
single-chamber ventricular pacing mode in patients with normal
sinus rhythm with complete heart block.
The study’s primary safety objective was met, with
no pauses or episodes of pacing-induced tachycardia reported during
algorithm mediated AV synchronous pacing in any of the 75
patients.
“The results of MARVEL 2 build on the original
promising MARVEL results and provide the strongest evidence to date
that accelerometer-based atrial sensing with the Micra leadless
pacemaker has the potential to provide improved AV synchrony in AV
block patients, who make up approximately 40% of the pacemaker
population worldwide,” said Rob Kowal, M.D., Ph.D., chief medical
officer, vice president of medical affairs in the Cardiac Rhythm
and Heart Failure division, which is part of the Cardiac and
Vascular Group at Medtronic. “This first-of-its-kind approach to
pacing is another example of Medtronic’s commitment to meaningful
product innovation that will help patients around the world.”
About the Micra Transcatheter Pacing System
(TPS)Approved by the U.S. Food and Drug Administration in April
2016 for patients who need a single-chamber pacemaker, the Micra
TPS is the first and only leadless pacemaker approved for use in
the U.S.
Comparable in size to a large vitamin, the Micra
TPS is less than one-tenth the size of traditional pacemakers yet
delivers the most advanced pacing technology to patients via a
minimally invasive approach. During the implant procedure, it is
attached to the heart with small tines and delivers electrical
impulses that pace the heart through an electrode at the end of the
device.
Unlike traditional pacemakers, the Micra TPS does
not require leads or a surgical "pocket" under the skin, so
potential sources of complications related to such leads and pocket
are eliminated - as are any visible signs of the device.
The Micra design incorporates a retrieval feature
which can be enabled, if necessary; however, the device is designed
to be left in the body. For patients who need more than one device,
the miniaturized Micra TPS can be permanently turned off, allowing
it to remain in the body so a new device can be implanted without
risk of electrical interaction. The Micra TPS is the first and only
leadless pacing system to be approved for both 1.5 and 3 Tesla
full-body magnetic resonance imaging (MRI) scans.
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. Medtronic 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 MedtronicMedtronic 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 90,000 people worldwide, serving physicians, hospitals and
patients in more than 150 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-
Ryan MathrePublic Relations+1-651-335-2338
Ryan WeispfenningInvestor Relations+1-763-505-4626
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