Alert Indications, Safety, and Warnings

LINQ II Insertable Cardiac Monitor (ICM) 

The LINQ II™ insertable cardiac monitoring system is the world's most accurate ICM,1-4 personalized for the patient's lifestyle and customized for the clinician's workflow. LINQ II ICM is ideal for patients experiencing infrequent symptoms that require long-term monitoring or ongoing management. 

Download LINQ II Brochure
LINQ II Insertable Cardiac Monitor device image on white background
Alert Indications, Safety, and Warnings

Overview

THE  FUTURE IS HERE

Meet LINQ II

New enhanced TruRhythm™ algorithms, remote programming, and 4.5 years* longevity.5

View Data
Learn about BlueSync
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UNMATCHED ACCURACY 

LINQ II Delivers the Lowest Published Rate of AF False Positives1-4

8x fewer false positives1-4

TRURHYTHM DETECTION PERFORMANCE: ICM FALSE POSITIVE RATE

A chart illustrating how LINQ II ICM delivers 8x fewer false positives and the lowest published rate of AF false positives compared to competitors

Disclaimer: A controlled, head-to-head study evaluating the comparative performance of these devices has not been done.

† Based on AF episodes ≥ 2 minutes and in known AF patients. % of false positives = (1 – episode PPV). AF episodes PPV may vary between gross and patient average.
‡ Confirm Rx™ with SharpSense™ technology & BIOMONITOR III have no published clinical evidence showing AF episode PPV or AF sensitivity. BioMonitor 2 has no published clinical evidence showing AF sensitivity.

1. Nölker G, Mayer J, Boldt LH, et al. Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. J Cardiovasc Electrophysiol. December 2016;27(12):1403-1410.
2. Confirm Rx™ ICM DM3500 FDA Clearance Letter. 2017.
3. Biotronik BioMonitor 2 Technical Manual. 2017.
4. Pürerfellner H, Sanders P, Sarkar S, et al. Adapting detection sensitivity based on evidence of irregular sinus arrhythmia to improve atrial fibrillation detection in insertable cardiac monitors. Europace. November 1, 2018;20(FI_3):f321-f328.

Exclusive Algorithms 

  • NEW pause detection algorithm reduces false pause detection by 79%.6
  • NEW PVC detector may help identify high-risk patients.7,8
  • Reduction in alerts9,10

Evolution of THE LINQ FAMILY OF ICMs

Reveal LINQ with
TruRhythm Detection Delivers§:

Chart showing the reduction in false detects and relative sensitivity of Reveal LINQ with TruRhythm Detection compared to Reveal LINQ

LINQ II with
TruRhythm Delivers||:

LINQ II with TruRhythm delivers a 79% reduction in false detects and a 100% relative sensitivity compared to the previous Reveal LINQ with TruRhythm

AF episode duration sensitivity used is ≥ 2 min.

§ Reveal LINQ with TruRhythm vs. Reveal LINQ.
|| LINQ II vs. Reveal LINQ with TruRhythm.

REIMAGINED CONNECTIVITY 

Increased Connectivity

BlueSync technology within LINQ II ICM enables secure, wireless communication via Bluetooth® Low Energy without compromising device longevity.5

  1. Reveal LINQ Mobile Manager
  2. LINQ II device
  3. MyCareLink Heart™ mobile app on patient's smartphone or tablet, or
  4. MyCareLink Relay™ home communicator for bedside use
  5. CareLink™ network
  6. Medtronic Stay Connected™, Get Connected, and Medtronic FocusOnSM Monitoring Service
Images of Reveal LINQ Mobile Manager and the LINQ II device
Images of MyCareLink Heart mobile app and MyCareLink Relay home communicator
Images of CareLink Network, Medtronic Stay Connected, Get Connected and Medtronic FocusOn Monitoring Service

EFFORTLESS CONNECTIVITY 

  • Portable Bluetooth® monitoring
  • Monitor automatically detects if new data is available
  • Event notification triggers an actionable alert

NO MANUAL TRANSMISSIONS  

  • Remote access to full ECGs eliminates the need for manual transmissions5
  • Decreases patient action and confusion

ENHANCED PATIENT COMPLIANCE 

  • Automatic smartphone notifications help patients stay connected
  • Reduces clinic time spent on patient follow-up 

STREAMLINED WORKFLOWS 

First ICM with Remote Programming#,5

  • May reduce patient office visits and scheduling hassles
  • Enables remote programming capability for all device parameters post-insertion from the clinic
  • 66% reduction in repetitive ECG data review12
  1. CareLink network
  2. Patient's smartphone or MyCareLink Relay home communicator
  3. LINQ II with BlueSync technology
An image illustrating the connection between CareLink network, patient's smartphone or home communicator, and the LINQ II device

Secure communication from CareLink to patient monitor to device.

Exclusive App-based Device Management Solution

The Reveal LINQ Mobile Manager tablet app makes it possible to manage all of your workflow needs, including13:

  • Device activation
  • Device programming
  • Performing follow-up checks
  • Customized patient education
An image of the Reveal LINQ Mobile Manager

33% TIME

SAVINGS FOR

REVIEWING ICM TRANSMISSIONS<sup>10</sup>

LINQ II ICM is projected to deliver efficiency gains for device clinics.

Fewer Alerts from New Algorithms and Nominal Settings

+

Elimination of

Manual Transmission

An image that shows LINQ II ICM transmission review time savings

LINQ II™ ICM Transmission Review Time Savings

More Time to focus on patient care

Over 200 Clinic Hours/Year Saved at clinics managing 200 ICMs14

Model Specifications 

pdf LINQ II Product Specifications (.pdf)

140KB

Document thumbnail

Resources 

Medtronic 24-hour support

800-505-4636

Educational Resources on Medtronic Academy

Find additional feature information along with a variety of educational resources and tools.

Visit Medtronic Academy

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Medtronic is under license.

*

Nominal settings.

†

Based on AF episodes ≥ 2 minutes and in known AF patients. % of false positives = (1 – episode PPV). AF episodes PPV may vary between gross and patient average.

‡

Confirm Rx™ with SharpSense™ technology & BIOMONITOR III have no published clinical evidence showing AF episode PPV or AF sensitivity. BioMonitor 2 has no published clinical evidence showing AF sensitivity.

§

Reveal LINQ with TruRhythm vs. Reveal LINQ.

||

LINQ II vs. Reveal LINQ with TruRhythm.

Medtronic FocusOnSM Monitoring Service is provided by Medtronic Monitoring Inc., a wholly owned subsidiary of Medtronic.

#

First European (TÜV notified body)-approved remote programmable device.

References

1

Nölker G, Mayer J, Boldt LH, et al. Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. J Cardiovasc Electrophysiol. December 2016;27(12):1403-1410.

2

Confirm Rx™ ICM DM3500 FDA Clearance Letter. 2017.

3

Biotronik BioMonitor 2 Technical Manual. 2017.

4

Pürerfellner H, Sanders P, Sarkar S, et al. Adapting detection sensitivity based on evidence of irregular sinus arrhythmia to improve atrial fibrillation detection in insertable cardiac monitors. Europace. November 1, 2018;20(FI_3):f321-f328.

5

LINQ II™ LNQ22 ICM Clinician Manual. M974764A001D.

6

Medtronic data on file. 2019.

7

Penela D, Van Huls Van Taxis C, Aguinaga L, et al. Neurohormonal, structural, and functional recovery pattern after premature ventricular complex ablation is independent of structural heart disease status in patients with depressed left ventricular ejection fraction: a prospective multicenter study. J Am Coll Cardiol. September 24, 2013;62(13):1195-1202.

8

Penela D, Fernández-Armenta J, Aguinaga L, et al. Clinical recognition of pure premature ventricular complex-induced cardiomyopathy at presentation. Heart Rhythm. December 2017;14(12):1864-1870.

9

Epstein AE, DiMarco JP, Ellenbogen KA, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. January 22, 2013;61(3):e6-e75.

10

Alert Analysis for Reveal LINQ™ with TruRhythm™ and LINQ II.™ Medtronic data on file. 2020.

11

Passman R, Rogers J, Sarkar S, et al. Development and validation of a dual sensing scheme to improve accuracy of bradycardia and pause detection in an insertable cardiac monitor. Heart Rhythm. 2017;14(7):1016-1023.

12

Van Heel L, Ousdigian K, Seiler A, Alfaro Vives C, Cheng Y-J, Rogers J. New Algorithms Reduce Clinician Review Burden and Maintain Diagnostic Yield for Repetitive ECGs in Insertable Cardiac Monitors. Circulation. November 11, 2019;140:A11830.

13

Reveal LINQ™ Mobile Manager 2.3 Online Help Instructions for Use.

14

Rosemas S. AF Algorithm Clinic Efficiency. Medtronic data on file. April 2020.