Medtronic Gains FDA Clearance, CE Mark for LINQ II™ Insertable Cardiac Monitor (ICM)
July 07 2020 - 9:15AM
Medtronic plc (NYSE:MDT), the global leader in medical
technology, today announced it has received U.S. Food and Drug
Administration (FDA) clearance and CE (Conformité
Européenne) Mark approval for its LINQ II™ insertable cardiac
monitor (ICM) with remote programming, which enables clinicians to
optimize device settings without the need for patients to return to
the office or hospital. The LINQ II system also delivers improved
device longevity (4.5 years*1) compared to other ICMs and enhanced
accuracy to correctly detect abnormal heart rhythms, simplifying
the diagnosis and monitoring of patients.
LINQ II is a small (one-third the size of a
AAA battery), wireless ICM for patients with abnormal heart rhythms
who experience infrequent symptoms including dizziness,
palpitations, syncope (fainting) and chest pain, thereby requiring
long-term monitoring or ongoing management. The device will be
commercially available in the U.S. and Europe later this
summer.
“In the current COVID-19 environment, the LINQ II
system offers patients a seamless way to experience ongoing
connectivity between their device and their physician, while
reducing the need for in-office visits,” said Rob Kowal, M.D.,
Ph.D., chief medical officer of the Cardiac Rhythm and Heart
Failure division, which is part of the Cardiac and Vascular Group
at Medtronic. “LINQ II gives physicians actionable data to help
diagnose underlying heart conditions and define treatment protocols
for patients with atrial fibrillation (AF) or other abnormal heart
rhythms.”
The LINQ II device incorporates many of the
features of LINQ with TruRhythm™ plus improvements that
differentiate the device from other ICMs:
- Accuracy and Streamlined Workflows: The LINQ II
device has the lowest published rates of AF false detections
compared to previous ICMs.2-5 It also has an
industry-exclusive Premature Ventricular Contraction (PVC) detector
to help with patient diagnosis; PVCs are extra, abnormal heartbeats
that begin in the ventricles, and disrupt the heart rhythm.
Additionally, clinicians spend 33 percent less time reviewing ICM
transmissions,6 resulting in potential office efficiencies and
reduced costs due to more streamlined workflows.
- Remote Programming: The LINQ II ICM offers remote
programming, which reduces the need for patients to come into the
office to have their device settings adjusted – a benefit for both
patients and physicians, especially during the current COVID-19
pandemic.
- Remote Patient Management: Patients with the LINQ
II ICM can choose one of two monitoring options to fit their
lifestyles and increase remote monitoring compliance, potentially
leading to improved patient outcomes:
-
- Patients can use their smartphones to automatically transfer
device data via the MyCareLink Heart™ mobile app using BlueSync™
technology that enables secure communication via Bluetooth.
- Patients who are unable or prefer not to use a cell phone can
transmit device data with the MyCareLink Relay™ Home
Communicator.
- Increased Longevity: The LINQ II device
offers an extended duration of continuous monitoring at 4.5
years*1. Continuous monitoring gives physicians greater
insights into patient data, aids in diagnoses and helps them manage
chronic cardiac arrhythmias.
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.
-end-
* Nominal settings
1LINQ II™ Clinician Manual.
M974764A001.2BiotronikBioMonitor™ 2 Technical Manual.
2017.3NölkerG, et al. J Cardiovasc Electrophysiol.
2016;27:1403-1410.4Confirm Rx™ ICM DM3500 FDA Clearance Letter.
2017. 5PürerfellnerH, et al. Europace. 2018;20:f321-f3286Alert
Analysis for LINQ II with TruRhythm and LINQ II, Medtronic data on
file, 2020.
Lauren MuellerPublic Relations+1-763-285-9053
Ryan WeispfenningInvestor Relations+1-763-505-4626
Medtronic (NYSE:MDT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Sep 2023 to Sep 2024