Alert Indications, Safety, and Warnings

LINQ II Insertable Cardiac Monitor (ICM) for cardiac monitoring

The LINQ II™ insertable cardiac monitoring system is 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 on transparent background
Alert Indications, Safety, and Warnings

Overview

Accuracy matters

LINQ II ICM is the world's most accurate ICM,1-13 featuring enhanced algorithms, remote programming, and 4.5-year† longevity.14

Watch this video to learn more about LINQ II ICM.

†Nominal settings.

Product details

Retained sensitivity

For greater confidence, the Atrial Fibrillation (AF) and Pause AccuRhythm™ AI algorithms further enhance the accuracy of the LINQ II ICM data.15-17

AF algorithm

99.3%
preserved true alerts16

99.96%
true AF detection retained

Pause algorithm

100%
preserved true alerts15

Discover AI algorithms

Lowest published rate of AF false positives

LINQ II ICM delivers eight times fewer false positives1,2,7,18

Chart demonstrating no published clinical evidence showing AF episode or AF sensitivity for Biotronik
Chart demonstrating the AF false positive percentages for Abbott
Chart depicting LINQ II ICM false positives

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

* Third-party brands are trademarks of their respective owners.
‡Lux-Dx™* ICM, Confirm Rx™* with SharpSense™* technology, Jot Dx™*, and BIOMONITOR™* III have no published clinical evidence showing AF episode PPV or AF sensitivity.
§ Based on AF episodes ≥ 2 minutes and in known AF patients. AF sensitivity may vary between gross and patient average.
1 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.
2 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.
7 BIOTRONIK BioMonitor™ 2 technical manual. 2017.
16 Radtke AP, Ousdigian KT, Haddad TD, Koehler JL, Colombowala IK. Artificial Intelligence Enables Dramatic Reduction of False Atrial Fibrillation Alerts from Insertable Cardiac Monitors. Heart Rhythm. August 1, 2021;18(8):S47.
18 Confirm Rx™* ICM DM3500 FDA clearance letter. 2017.​

Industry-exclusive PVC algorithm

The exclusive PVC detector may help identify high-risk patients.19,20

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Product features

Increased connectivity. Seamless experience.

BlueSync™ technology within LINQ II ICM enables secure, wireless communication via Bluetooth® Low Energy without compromising device longevity.14

  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 Get Connected and Stay Connected
CareLink network screen on a desktop computer and portrait of a woman smiling

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 transmissions14
  • Decreases patient action and confusion

Enhanced patient compliance

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

First ICM with remote programming||14

LINQ II ICM enables remote programming capability for all device parameters post-insertion from the clinic, which may reduce patient office visits and scheduling hassles.

Man with a gray beard looking at his mobile phone outside with trees in the background

Patient data transmitted to CareLink network via MyCareLink Relay or MyCareLink Heart

Female healthcare professional wearing scrubs while typing on a computer

Clinician-initiated reprogramming via CareLink network

MyCareLink Relay home communicator and MyCareLink Heart mobile app monitors

Monitors act as a
pass-through

Man with a gray beard looking at his mobile phone outside with trees in the background

Device settings automatically update without need for an office visit

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

More time to focus on patient care

AccuRhythm AI algorithms can save clinicians approximately 319 hours of false alert review yearly for every 200 LINQ II ICM patients.¶21

  

84%
reduction in LINQ II false alerts21

319
hours reduction in clinic review time¶21

The validation study performance and time study results were projected onto 16,301 LINQ II patients to calculate the time saved per year in 200 LINQ II ICM patients.

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Model Specifications 

pdf LINQ II product specifications (.pdf)

Download the specifications sheet for details on the LINQ II insertable cardiac monitor.

151KB

Document thumbnail

Resource library

Related pages

Medtronic 24-hour support

1-800-505-4636

Educational resources on Medtronic Academy

Access interactive courses, videos, and educational resources to extend your learning on LINQ II ICM.

Visit Medtronic Academy

Medtronic, Medtronic logo, and Engineering the extraordinary are trademarks of Medtronic. 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. ™Other third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.

*

Third-party brands are trademarks of their respective owners.

†

Nominal settings.

‡

Lux-Dx™* ICM, Confirm Rx™* with SharpSense™* technology, Jot Dx™*, and BIOMONITOR™* III have no published clinical evidence showing AF episode PPV or AF sensitivity.

§

Based on AF episodes ≥ 2 minutes and in known AF patients. AF sensitivity may vary between gross and patient average.

||

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

The validation study performance and time study results were projected onto 16,301 LINQ II patients to calculate the time saved per year in 200 LINQ II ICM patients.

References

1

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 2018;20(FI_3):f321-f328.

2

Nölker G, Mayer J, Boldt L, 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.

3

Confirm Rx™ ICM K163407 FDA clearance letter. 2017.

4

Confirm Rx ICM K182981 FDA clearance letter. 2019.

5

Jot Dx™ ICM K212206 FDA clearance letter. 2021.

6

Monitoring Devices Merlin PCS Help Manual for SJM Confirm, Confirm Rx ICM, Jot Dx Manual. 2021.

7

BIOTRONIK BioMonitor™ 2 technical manual. 2017.

8

BIOTRONIK BIOMONITOR III technical manual. 2020.

9

BIOTRONIK BIOMONITOR IIIm technical manual. 2020.

10

BIOTRONIK BIOMONITOR III. K190548 FDA clearance. 2019.

11

BIOTRONIK BIOMONITOR IIIm. K201865 FDA clearance. 2020.

12

Lux-Dx™ ICM K212206 FDA clearance letter. 2020.

13

Lux-Dx ICM user manual. 2020.

14

LINQ II™ LNQ22 ICM clinician manual. M974764A001D.

15

Cheng YJ, Ousdigian KT, Koehler J, Cho YK, Kloosterman M. Innovative Artificial Intelligence Application Reduces False Pause Alerts while Maintaining Perfect True Pause Sensitivity for Insertable Cardiac Monitors. Presented at HRS 2021.

16

Radtke AP, Ousdigian KT, Haddad TD, Koehler JL, Colombowala IK. Artificial Intelligence Enables Dramatic Reduction of False Atrial Fibrillation Alerts from Insertable Cardiac Monitors. Heart Rhythm. August 1, 2021;18(8):S47.

17

AccuRhythm clinician manual supplements M015316C001 and M015314C001.

18

Confirm Rx™* ICM DM3500 FDA clearance letter. 2017.

19

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.

20

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.

21

Ousdigian K, Cheng YJ, Koehler J, et al. Artificial Intelligence Dramatically Reduces Annual False Alerts from Insertable Cardiac Monitors. Presented at AHA Conference 2021.