AI Algorithms Enhance LINQ II™ Insertable Cardiac Monitor
Diagnostic Accuracy for Improved Management of Patients
DUBLIN, July 28, 2021 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced U.S. Food and Drug Administration (FDA) clearance for two
AccuRhythm™ AI algorithms for use with the LINQ II™ insertable
cardiac monitor (ICM). AccuRhythm AI applies artificial
intelligence (AI) to heart rhythm event data collected by LINQ II,
improving the accuracy of information physicians receive so they
can better diagnose and treat abnormal heart rhythms. AccuRhythm AI
validation data will be presented this week at Heart Rhythm 2021,
the Heart Rhythm Society's annual Heart Rhythm meeting.
The small, wireless LINQ II ICM is the world's most accurate
ICM,1-4 and the new cloud-based AccuRhythm AI algorithms
further enhance LINQ II ICM's delivery of accurate heart rhythm
alerts. The algorithms address the two most common ICM false alerts
– atrial fibrillation (AF), an irregular or rapid rhythm in the
upper chambers of the heart; and asystole, a long pause between
heartbeats.5-6 Medtronic developed the AccuRhythm
AI platform and initial algorithms using its proprietary, diverse
and debiased database of more than 1 million electrocardiogram
heart rhythm episodes.
AccuRhythm AI validation results to be presented at Heart Rhythm
2021 include:
- The AF algorithm reduced LINQ II ICM false AF alerts by 74.1%
and preserved 99.3% of true AF alerts.
- The Pause algorithm reduced LINQ II false pause alerts by 97.4%
and preserved 100% of true pause alerts.
"Applying AccuRhythm AI to LINQ II data is a significant ICM
innovation, enabling us to reduce clinical inefficiencies resulting
from false alerts, and help physicians better identify and focus on
the actionable data they need to treat their patients," said
Rob Kowal, M.D., Ph.D., chief
medical officer of the Cardiovascular Diagnostics and Services
business, which is part of the Cardiovascular Portfolio at
Medtronic.
The AccuRhythm AI algorithms will be released on the
CareLink™ Network later this year for use by all implanted
LINQ II devices in the United
States.
"We are excited to integrate AI capabilities to further elevate
the accuracy of LINQ II ICM – and provide clinicians with greater
confidence in patient care decisions," said Julie Brewer, president of the Cardiovascular
Diagnostics and Services business at Medtronic. "We look forward to
introducing additional diagnostic innovations to advance patient
management in the future."
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.
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 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.
1BiotronikBioMonitor™ 2 Technical Manual. 2017.
2NölkerG, et al. J Cardiovasc Electrophysiol.
2016;27:1403-1410.
3Confirm Rx™ ICM DM3500 FDA Clearance Letter. 2017.
4PürerfellnerH, et al. Europace. 2018;20:f321-f328.
5Catherine O`Shea, Melissa E.
Middeldorp, Anthony G.
Brooks, Jeroen M. Hendriks,
Celine Gallagher, Niraj Varma, Rakesh Gopinathannair, Suzanne A. Feigofsky, Dennis H. Lau, Kevin R.
Campbell, Prashanthan Sanders. Remote Monitoring Of
Implantable Loop Recorders: False-positive Alert Episodes. Poster
presented at: HRS 2020 Science Online. May
2020.
https://cslide-us.ctimeetingtech.com/hrs20/attendee/eposter/poster/71.
6AccuRhythm Clinician Manual Supplements M015316C001 and
M015314C001.
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SOURCE Medtronic plc