Medtronic Clinical Trial to Evaluate ECG Belt for Optimizing Heart Failure Therapy
July 19 2018 - 11:30AM
DUBLIN - July 19, 2018 -
Medtronic plc (NYSE: MDT) today announced first enrollments in
a new clinical trial evaluating the ECG (electrocardiography) Belt
Research System (ECG Belt) as a diagnostic tool for optimizing
cardiac resynchronization therapy (CRT) for patients with heart
failure. The first patient enrolled in the ECG Belt for CRT
Response trial was at Mercy Medical Center - West Lakes in Des
Moines, Iowa, by Troy Hounshell, D.O., Iowa Heart Center. The ECG Belt is investigational and not approved for sale
in the United States.
ECG Belt for CRT Response is a prospective,
randomized, interventional, investigational study that will
initially enroll patients in 10 centers across the U.S. The trial
will compare patients treated with CRT and ECG Belt diagnostics to
patients treated with standard CRT. The study will expand to
additional sites worldwide to ensure a total of 400 randomized
patients.
CRT is an established treatment option for
indicated patients with heart failure in which an implantable
device sends low levels of energy through thin wires, called leads,
to stimulate the lower chambers of the heart to improve its pumping
efficiency. The therapy has been demonstrated to improve survival
and quality of life, and to reduce hospitalizations.
"The aim of this technology is to give physicians
immediate feedback that may impact clinical decision making at the
time of implant and also during follow-up visits," said Dr.
Hounshell, electrophysiologist at Iowa Heart Center, and the site's
principal investigator in the study. "By pairing CRT with the ECG
Belt, we have the potential to provide a more personalized and
noninvasive approach to help heart failure patients."
Using the ECG Belt during the trial, clinicians
will assess the heart's electrical activity through real-time
synchronization measurements. At the time of CRT device implant,
the ECG Belt will be applied externally to patients' bodies,
wrapped around the chest and back, to help physicians guide
placement of the left ventricular lead. The ECG Belt will be used
again at follow-up visits to further optimize the device's
programmed settings.
"Our goal for this study is to give clinicians
real-time insights to address each patient's needs, and to help
optimize CRT for heart failure patients," said Kweli P. Thompson,
M.D., M.P.H., vice president and general manager of the Cardiac
Resynchronization Therapy business, which is part of the Cardiac
Rhythm and Heart Failure division at Medtronic.
The Medtronic portfolio of therapies, diagnostic
tools and services for patients suffering from heart failure
includes CRT devices, including MR-conditional CRT-Ds and CRT-Ps;
mechanical circulatory support therapy for advanced heart failure
patients; heart failure diagnostics; and meaningful expert analysis
through Medtronic Care Management Services.
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 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 86,000 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-
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq 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
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