FDA Approves Medtronic Micra™ AV, the World’s Smallest Pacemaker Which Can Now Treat AV Block
22 January 2020 - 4:01AM
Medtronic plc (NYSE:MDT) today announced it has received
U.S. Food and Drug Administration (FDA) approval of Micra™ AV, the
world’s smallest pacemaker with atrioventricular (AV) synchrony.
Micra AV is indicated for the treatment of patients
with
AV block, a condition in which the
electrical signals between the chambers of the heart (the atria and
the ventricle) are impaired. Medtronic now offers the first
and only FDA-approved leadless pacemaker portfolio, expanding the
number of potential candidates for this groundbreaking technology
in the U.S.
“With the approval of Micra AV, more pacemaker
patients qualify for a new treatment option that offers the
advantages of leadless pacing – including a minimally invasive
implant procedure and a cosmetically invisible device,” said Larry
Chinitz, M.D., cardiac electrophysiologist and director of NYU
Langone’s Heart Rhythm Center in New York City. “Although
complications with traditional pacemakers are infrequent, when they
occur, they’re expensive to treat and can be invasive for the
patient. Real-world use of Micra has shown a 63% reduction in
major complications compared to traditional pacemakers.”
Historically, patients with AV block have been
treated with traditional dual-chamber pacemakers which are
implanted in the upper chest, under the skin below the collar bone,
and connected to the heart using thin wires called “leads.”
Identical in size and shape to the original Micra Transcatheter
Pacing System (TPS), Micra AV has several additional internal
atrial sensing algorithms which detect cardiac movement, allowing
the device to adjust pacing in the ventricle to coordinate with the
atrium, providing “AV synchronous” pacing therapy to patients with
AV block.
The Micra AV approval is based on data from the
MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer)
study, which evaluated the safety and effectiveness of
accelerometer-based atrial sensing algorithms. The study evaluated
the ability of the Micra’s internal sensor to monitor and detect
atrial contractions and enable coordinated pacing between the
atrium and ventricle, thereby providing AV
synchrony. Results from the study, presented
at the American Heart Association 2019 Scientific Sessions and
published simultaneously in JACC: Clinical Electrophysiology,
showed the 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 study’s primary safety objective
was also met, with no pauses or episodes of pacing-induced
tachycardia reported during algorithm mediated AV synchronous
pacing.
Medtronic will begin training field personnel and
physicians, and will activate a limited number of implanting
centers in the coming weeks, with full launch anticipated later
this spring.
“Since revolutionizing medicine with the
first battery-powered cardiac pacemakers, Medtronic has continued
to develop pioneering pacing technologies, culminating in the first
miniaturized, leadless pacing portfolio for physicians and their
patients,” 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. “The introduction of Micra AV reinvents our own
innovation, bringing the many benefits of leadless pacemakers to
more patients.”
About the Micra Transcatheter Pacing
System (TPS)Approved by the FDA in 2016, the Micra TPS is
a leadless pacemaker option for patients who only require pacing in
the right ventricle. Comparable in size to a large vitamin, Micra
is less than one-tenth the size of traditional pacemakers yet
delivers advanced pacing technology to patients via a minimally
invasive approach. During the implant procedure, the device 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, Micra does not
require leads or a surgical "pocket" under the skin, so potential
sources of complications related to leads and pockets are
eliminated - as are any visible signs of the device.
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.
To view an animation of the Micra AV in use, click
here. (with no-voice over, click here)
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
- Micra™ AV
- Micra™ AV in heart
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