Medtronic CardioInsight Mapping Solution Cleared by FDA
February 01 2017 - 9:00AM
System First Used
Commercially in U.S. This Week
DUBLIN - Feb. 1, 2017
- Medtronic plc (NYSE: MDT) has received U.S. Food and
Drug Administration (FDA) 510(k) clearance for the
CardioInsight(TM) Noninvasive 3D Mapping System. The CardioInsight
system is used to map a wide range of irregular heart rhythms in
the upper and lower chambers of the heart, and provides
electroanatomic 3D maps of the heart. The system was first used
commercially in the U.S. by Vivek Reddy, M.D., director of cardiac
arrhythmia services at the Mount Sinai Hospital and the Mount Sinai
Health System, New York.
Cardiac mapping - typically accomplished by
inserting a catheter into the heart via an artery or vein - allows
physicians to locate the origin of a patient's irregular heart
rhythms (arrhythmias). In contrast, the CardioInsight system is the
first commercially released, noninvasive, cardiac electrical
mapping system in the world, eliminating the invasive steps of this
clinical procedure.
The CardioInsight system uses a 252-electrode
sensor vest that is worn by the patient to pair body surface
electrical data with heart-torso anatomy. The noninvasive
technology creates 3D electroanatomic maps of the heart by
collecting electrocardiogram (ECG) signals from the chest, and
combining these signals with data from a computed tomography (CT)
scan of the heart. The vest technology contours to the patient's
body and allows for continuous and simultaneous panoramic mapping
of both atria or both ventricles, which cannot be achieved with
current invasive methods. The 3D cardiac maps can be created by
capturing a single heartbeat, and enable rapid mapping of these
heart rhythms. The predecessor system has been used with more than
1,600 patients and is featured in more than 120 peer-reviewed
journals and presentations.
"By offering this noninvasive approach, we are
effectively streamlining the clinical procedure planning process
for clinicians, and making it easy for patients to receive precise
mapping results from their providers right at their bedside," said
Dr. Reddy. "This system shifts mapping away from the EP lab,
potentially saving time and enhancing the patient experience." Dr.
Reddy receives financial compensation as a consultant to Medtronic,
as well as research grant support from Medtronic.
Medtronic will employ a strategic rollout of the
technology in the geographies where it is cleared. Medtronic
acquired CardioInsight in 2015, now part of the Medtronic AF
Solutions business in the Cardiac Rhythm and Heart Failure
division.
"The CardioInsight system further expands the
portfolio of solutions available for common and complex
arrhythmias," said Colleen Fowler, vice president and general
manager of the AF Solutions business. "This technology - which has
been in development for decades - is now poised to drive greater
physician insights and new advancements in the study and treatment
of infrequent, unstable cardiac rhythms in a noninvasive,
patient-friendly manner."
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.
To view animation of the CardioInsight System in
use, click here http://oak.ctx.ly/r/5ea9h.
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-
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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