Item number | Description |
---|---|
LNQ11 | Reveal LINQ™ insertable cardiac monitor (ICM) |
Insertable cardiac monitors
Reveal LINQ™ insertable cardiac monitor
<p>The Reveal LINQ™ ICM with AccuRhythm™ AI algorithms is for patients with infrequent symptoms requiring long-term cardiac monitoring.</p>
Features
Overview
Powerfully small and simple
- The Reveal LINQ™ ICM is one-third the size of a AAA battery (1.2 mL).
- It has a minimally invasive, simplified insertion procedure.
- The device is 1.5T and 3T MRI Conditional with no post-insertion waiting required.‡
Not actual size
AccuRhythm™ AI algorithms
Experience the difference of Reveal LINQ™ ICM with AccuRhythm™ AI algorithms for atrial fibrillation (AF) and pause.
Trusted in over one million implants,5 Reveal LINQ™ ICM is the most studied ICM in the market5 and is enhanced with proven AI. AccuRhythm™ AI algorithms for AF and pause provide smarter, more actionable data — without compromise.4
Preserving over 99.9% true pause and 98.2% true AF alerts relative to Reveal LINQ™ ICM, AccuRhythm™ AI algorithms significantly improve the clinic experience.4
Learn more about AccuRhythm™ AI algorithms. (03:32)
How are AccuRhythm™ AI algorithms applied?
Data workflow
The AccuRhythm™ AI platform applies deep learning AI algorithms to Reveal LINQ™ ICM data flowing into the CareLink™ network to remove false AF and pause alerts and significantly reduce clinic review burden.5
- Reveal LINQ™ ICM
- Data transmitted to the cloud
- Medtronic CareLink™ network
- AF and pause episodes
- AccuRhythm™ AI algorithms
- False events
- True or indeterminant events
Reduce false alerts.
AF and pause generate ~90% of false alerts in the ICM space.6 AccuRhythm™ AI algorithms can save clinicians approximately 205 hours of false alert review yearly for every 200 Reveal LINQ™ ICM patients.§,◊,5 85% cumulative reduction in Reveal LINQ™ ICM false alerts.4
Exclusive services and solutions
1. Streamline device programming and interrogation
Reveal LINQ™ mobile manager is a single, app-based solution for managing:
- Device registration, activation, and CareLink™ pre-enrollment
- Guided workflow animations
- Integrated patient education
2. One of the world’s smallest and most accurate ICMs.1–3
Reveal LINQ™ ICM is part of the exclusive services and solutions designed to get you back to caring for patients.
3. Direct support for patient monitor connectivity issues
Medtronic Stay Connected service is a specialized patient service for monitor troubleshooting, connectivity issues, and other questions:
Direct patient line for fast service: 1-866-470-7709
7 a.m.–7 p.m. CT, Monday–Friday
4. Customize alerts for clinically actionable reports
CareLink™ network is a remote monitoring network that enables data-driven care decisions:
- CareAlert™ notifications allow for customized reports by clinic and/or individual patient
- Cardiac Compass™ report provides a 90-day view of patient cardiac data
Accuracy matters. Discover the Reveal LINQ™ ICM.
Watch an ICM insertion procedure animation video. (02.43)
Conditionally safe MRI access SureScan™ technology
Reveal LINQ™ ICM is MR Conditional at 1.5T and 3T with no post-insertion waiting required.
Reveal LINQ™ insertable cardiac monitor MRI conditions for use:
A patient with a Reveal LINQ™ ICM can be safely scanned in an MR system that meets the following conditions with no post-insertion waiting required. Failure to follow these conditions for use may result in a hazard to the patient during an MRI scan:
- Horizontal cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) or 3T must be used.
- Hydrogen proton MRI equipment must be used.
- Maximum spatial gradient of the static magnetic field specification must be ≤ 25 T/m (2500 gauss/cm).
- Whole body gradient systems with gradient slew rate specification must be ≤ 200 T/m/s per axis.
- The Whole Body Specific Absorption Rate (WB-SAR) as reported by the MRI equipment must be ≤ 4.0 W/kg; the head SAR as reported by the MRI equipment must be ≤ 3.2 W/kg.
- Do not use local transmit coils on the chest, trunk, or shoulder region.
- There are no restrictions on the placement of receive-only coils, and there are no restrictions on the use of local transmit or receive coils for imaging of the head or extremities.
Clinical evidence
When patients have unexplained or intermittent symptoms with a suspected cardiac cause, 30 days of monitoring may not be sufficient. The Reveal LINQ™ ICM works continuously to capture comprehensive and actionable data over a longer period of time than short-term monitors to deliver superior yield that can increase the rate of diagnosis for patients with atrial fibrillation (AF), cryptogenic stroke, and unexplained syncope.
- Diagnose syncope sooner.
- Cardiologists are 3.6 times more likely to reach a diagnosis with ICMs vs. conventional monitors for unexplained syncope. #,11
- Between 70%-86% of patients diagnosed with ICMs would remain undiagnosed utilizing conventional monitoring strategies. ∆,12
- Identify AF in high-risk patients.
- Clinical evidence shows 84.5% of patients at high risk of stroke and AF would have had their AF diagnosis missed with a single-use, 30-day monitor.∆,13 Cardiologists are 4.3 times more likely to reach an AF diagnosis with ICMs.14–17
- Inform secondary stroke prevention strategies.
- Up to 30% of patients with cryptogenic stroke may have previously undetected paroxysmal AF,18, 19 but 30-day monitors fail to detect AF in 88% of these patients.∆18 When AF is detected by an ICM and treated, the risk of stroke recurrence is reduced by 55%.20
- Manage AF with data-guided decisions.
- Find more actionable data with the LINQ™ family of ICMs, which offer the highest AF detection accuracy rate of 99.7%.21 Continuous cardiac monitoring with the Reveal LINQ™ ICM captures AF burden, heart rate variability, and daily activity data to help cardiologists assess treatment effectiveness and determine when to try a new approach.
Ordering information
† Reference the Reveal LINQ™ ICM clinician manual for usage parameters.
‡ Reveal LINQ™ has demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use. Please see the Reveal LINQ™ MRI technical manual for more details.
§ The validation study performance and time study results were projected onto 86,383 Reveal LINQ™ patients to calculate false alert reduction per year in 200 Reveal LINQ™ ICM patients.
◊ Estimated time savings was calculated based on 11.3 minutes per non-actionable ICM transmission.6
¶ The CRYSTAL-AF Study was a randomized, controlled study conducted on 441 patients to assess whether long-term monitoring with Reveal™ XT is more effective than conventional follow-up (control) for detecting atrial fibrillation in patients with cryptogenic stroke.
# 2018 ESC Guidelines for Diagnosis and Management of Syncope defined conventional testing as undefined physician discretion for monitoring excluding ICM, External Loop Recorder, Tilt Test, EP Study, Recurrent 12-lead ECG, or 7-day Holter monitor.
∆ Based on Kaplan-Meier estimates
- Reveal LINQ™ insertable cardiac monitor clinician manual.
- Assert-IQ™ Model DM5000, DM5300, DM5500, insertable cardiac monitor manual. 2023.
- ICM accuracy comparison guide. Medtronic data on file. 2021.
- Radtke AP et al. AI enables significant reduction of clinic review burden for legacy ICMs. Heart Rhythm 2024; 21(5) Supplement: S261. doi: 10.1016/j.hrthm.2024.03.850.
- Medtronic Reveal™ ICM family data. Data on file. 2024.
- O’Shea CJ, Middeldorp ME, Hendriks JM, et al. Remote monitoring of implantable loop recorders: false-positive alert episode burden. Circ Arrhythm Electrophysiol. 2021;14(11):e009635. doi: 10.1161/CIRCEP.121.009635.
- ICM Size Comparison Guide. Medtronic data on file. 2020.
- ICM Publications. Medtronic data on file. 2023.
- Rogers JD, Piorkowski C, Sohail MR, et al. Resource utilization associated with hospital and office-based insertion of a miniaturized insertable cardiac monitor: results from the RIO 2 randomized US study. J Med Econ. July 2020;23(7):706–713.
- Rogers JD, Sanders P, Piorkowski C, et al. In-office insertion of a miniaturized insertable cardiac monitor: Results from the Reveal LINQ In-Office 2 randomized study. Heart Rhythm. 2017;14(2):218–224.
- Brignole M, Moya A, de Lange FJ, et al. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. Published online 2018.
- Rogers JD, Higuera L, Rosemas SC, Cheng Y, Ziegler PD. Diagnostic Sensitivity and cost per diagnosis of ambulatory cardiac monitoring strategies in unexplained syncope patients. PLoS One. June 24, 2022;17(6):e0270398.
- Reiffel JA, Verma A, Kowey PR, et al. Rhythm monitoring strategies in patients at high risk for atrial fibrillation and stroke: A comparative analysis from the REVEAL AF study. Am Heart J. 2020;219:128-136.
- Brignole M, Moya A, de Lange FJ, et al. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018;39:1883-1948.
- Rogers JD, Higuera L, Rosemas SC, Cheng Y, Ziegler PD. Diagnostic Sensitivity and cost per diagnosis of ambulatory cardiac monitoring strategies in unexplained syncope patients. PLoS One. June 24, 2022;17(6):e0270398.
- Healey JS, Alings M, Ha A, et al. Subclinical Atrial Fibrillation in Older Patients. Circulation. 2017;136(14):1276-1283.
- Philippsen TJ, Christensen LS, Hansen MG, Dahl JS, Brandes A. Detection of Subclinical Atrial Fibrillation in High-Risk Patients Using an Insertable Cardiac Monitor. JACC Clin Electrophysiol. 2017;3(13):1557-1564.
- Sanna T, Diener H, Passman RS, et al. Cryptogenic Stroke and Underlying Atrial Fibrillation. N Engl J Med. 2014;370;26:2478-2486.
- Brachmann J, Morillo CA, Sanna T, et al. Uncovering Atrial Fibrillation Beyond Short-Term Monitoring in Cryptogenic Stroke Patients: Three-Year Results From the Cryptogenic Stroke and Underlying Atrial Fibrillation Trial Circ Arrhythm Electrophysiol. 2016;9:e003333.
- Tsivgoulis G, Katsanos AH, Grory BM, et al. Prolonged Cardiac Rhythm Monitoring and Secondary Stroke Prevention in Patients With Cryptogenic Cerebral Ischemia. Stroke. 2019;50:2175-2180.
- TruRhythm Detection Algorithms. Medtronic data on file. 2017.