New Data Further Demonstrate Safety Benefits for World's Smallest Pacemaker
June 09 2016 - 8:00AM
Data
Featured In Late-Breaking Trial Session at Cardiostim 2016 Show
Micra TPS Safety Benefits Maintained Beyond Six Months
DUBLIN and
NICE, FRANCE - JUNE 9, 2016 - Medtronic plc (NYSE:MDT) today
announced new results from the Medtronic Micra® Transcatheter
Pacing System (TPS) Global Clinical Trial in a late-breaking trial
session at CARDIOSTIM / EHRA EUROPACE 2016, the World Congress in
Electrophysiology and Cardiac Techniques, in Nice, France.
The new follow-up data on patients enrolled in the
pre-market Micra TPS Global Clinical Trial underscore the safety
benefits of the Micra TPS, with only 3.7 percent of patients (27 of
726; Kaplan-Meier estimate) experiencing a major complication, and
no patients (0) experiencing a device dislodgement, at 7.7 months
of follow-up.
The results showed that at 7.7 months, the risk
for major complications with Micra is significantly lower - 52
percent lower - than the risk associated with conventional pacing
systems (hazard ratio: 0.48; 95 percent CI, 0.32 to 0.72; P<0.001). In addition, the risk for major
complications was lower for the Micra TPS relative to conventional
systems across all patient sub-groups, whether measured by age, sex
or comorbidity (all hazard ratios < 1.0).
"Clinicians are extremely pleased that the
evidence continues to demonstrate the strong safety profile of the
Micra for all patient groups," said Dr. Gabor Duray, head of
Clinical Electrophysiology and Pacing, State Health Center,
Budapest, Hungary. "These data provide the largest sample and the
longest follow-up reported for this technology to date. We look
forward to further evaluating this minimally invasive, leadless
option in patients across the world."
The Micra TPS is less than one-tenth the size of
traditional pacemakers and the only leadless pacemaker approved for
use in both the U.S. and Europe. 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.
At 7.7 months, Micra TPS continued to
provide low and stable pacing thresholds, yielding projected
average longevity for the device of more than 12 years based on
device use conditions through six-months on 590 patients. This
longevity rate is similar to conventional pacing systems
(references Hauser, et al Heart Rhythm 2007 and Senaratne, et al
PACE 2006).
In November 2015, preliminary results from the
Medtronic Micra TPS Global Clinical Trial were published in the
New England Journal of Medicine and presented
during a late-breaking Special Report at the American Heart
Association Scientific Sessions. Data showed the Micra TPS was
successfully implanted in 99.2 percent of patients and the system
met its safety and effectiveness endpoints with wide margins. Data
from beyond six months, presented today at Cardiostim 2016,
reinforced these results with no (0) dislodgments, and no (0)
systemic infections. These low complication rates were achieved
despite the inclusion of high-risk patients in the study worldwide,
including patients with chronic obstructive pulmonary disease
(COPD).
"The Micra delivers vital pacing therapy to
patients, while also providing a less invasive alternative than
other pacemaker therapies on the market," said John Liddicoat,
M.D., senior vice president, Medtronic, and president of the
Cardiac Rhythm and Heart Failure division. "This novel technology
continues to demonstrate a low rate of major complications, both
during and after implant, in a diverse group of patients. We're
pleased these new longer-term data further underscore the safety
profile of Micra."
Micra's design incorporates a retrieval feature to enable retrieval
when possible; however, the device is designed to be left in the
body. For patients who need more than one device, the miniaturized
Micra TPS was designed with a unique feature that enables it to be
permanently turned off so it can remain in the body and a new
device can be implanted without risk of electrical interaction.
The Micra TPS was awarded CE Mark in April 2015
and U.S. Food and Drug Administration (FDA) approval in April 2016.
It is intended for use in patients who need a single-chamber
pacemaker. Micra is the first and only leadless pacing
system to be approved for both 1.5 and 3 Tesla (T) full-body
magnetic resonance imaging (MRI) scans, providing patients with
access to the most advanced imaging diagnostic procedures
available. The device was designed to allow patients to be followed
by their physicians and send data remotely via the Medtronic
CareLink® Network; remote monitoring of Micra devices is expected
to be available later this year.
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
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 85,000 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-
Contacts:
Ryan Mathre
Public Relations
+1-763-514-9625
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX 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
HUG#2018390
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2024 to May 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From May 2023 to May 2024