Fact-checked by Grok 2 weeks ago

Implantable loop recorder

An implantable loop recorder (ILR), also known as an insertable cardiac or implantable event recorder, is a small, subcutaneous device approximately the size of a USB drive that is implanted under the skin of the chest to continuously and record the heart's electrical activity, or electrocardiogram (ECG), for up to three years. It features two electrodes and operates by detecting and storing episodes of irregular heart rhythms, either automatically through built-in algorithms or manually when the patient activates it during symptoms such as or . Data from the device is wirelessly transmitted to a bedside or directly to healthcare providers for analysis, enabling remote monitoring without restricting daily activities like bathing or exercise. ILRs are primarily indicated for diagnosing infrequent or elusive cardiac arrhythmias that may not be captured by shorter-term methods like Holter monitors or external event recorders. Common clinical uses include investigating unexplained syncope (fainting), recurrent , , , or following a , where symptoms occur too sporadically for conventional diagnostics. They also aid in assessing the effectiveness of treatments or high-risk patients, such as those with cryptogenic , by providing long-term ECG data that can reveal brief or intermittent abnormalities. Studies have shown ILRs to have a detection rate of up to 75% for the causes of syncope within three years of implantation. The implantation procedure is minimally invasive, typically performed as an under in a medical office or catheterization lab, involving a small incision (about 1 cm) over the fourth to place the device subcutaneously. The process takes 15-30 minutes, with patients able to resume normal activities shortly after, though the site requires for minor risks like , , or bruising, which occur in fewer than 1% of cases. Most modern ILRs are MRI-conditional, allowing safe imaging if needed, and their battery life supports extended without frequent interventions. Once the diagnostic purpose is fulfilled, the device can be surgically removed or deactivated.

Device Overview

Definition and Purpose

An implantable loop recorder (ILR), also known as an insertable cardiac monitor (ICM), is a small device implanted subcutaneously in the chest to continuously and a patient's electrocardiogram (ECG) signals for the detection of irregular heart rhythms. This diagnostic tool is particularly valuable for capturing infrequent or cardiac events that may not be detected by shorter-term monitoring methods. The primary purpose of an ILR is to aid in the of elusive arrhythmias, such as unexplained syncope or , by providing extended monitoring capabilities lasting up to 3 years, depending on the device model and usage. Key benefits include patient-activated recording, which allows individuals to manually trigger data capture during symptomatic episodes, and built-in automatic detection algorithms that identify and store abnormal rhythms without user intervention. These features enhance diagnostic accuracy by correlating symptoms with ECG data over prolonged periods. The Reveal, the first ILR, received FDA approval in 1998, representing a significant advancement in enabling continuous, long-term cardiac rhythm surveillance beyond the limitations of external devices like Holter monitors.

Components and Design

The implantable loop recorder (ILR) consists of several core components designed for reliable long-term cardiac monitoring. At its heart are integrated electrodes, typically two self-contained subcutaneous electrodes positioned on the device's surface to sense electrocardiogram (ECG) signals without external leads. A serves as the , handling signal amplification, filtering, and analysis to detect arrhythmic events. storage, often in the form of non-volatile , enables continuous looping recording with capacity for patient-activated episodes or automatic triggers, supporting equivalent to 1-3 years of monitoring depending on event frequency. Power is provided by a compact -based , such as lithium carbon monofluoride, which typically lasts 2-3 years under standard usage conditions, with newer models like the LINQ II extending up to 4.5 years as of 2025. Design features emphasize , compactness, and ease of implantation to minimize patient discomfort and complications. The device is encased in a hermetically sealed made from MRI-conditional materials like for the header and or for the body, ensuring durability and safety in imaging environments up to 1.5-3 . It is intended for subcutaneous placement in the left anterior chest, typically in the parasternal region at the level of the 4th , allowing for a minimally invasive insertion procedure via a small incision. Dimensions vary by model but prioritize slim profiles; for instance, early devices measured approximately 61 mm × 19 mm × 8 mm, while modern iterations are significantly slimmer at around 45 mm × 7 mm × 4 mm. The evolution of ILR design has focused on progressive to enhance acceptance and procedural simplicity, reducing from initial prototypes weighing over 15 grams and occupying volumes around 9 mL to contemporary models approximately 2.5 grams and 1.2 mL in volume. This downsizing, achieved through advances in and battery technology, has decreased device footprints by up to 87% while maintaining or extending functional longevity. Recent advancements include integration of algorithms for improved detection and reduced false alerts, as seen in 's Reveal LINQ updates in 2024. A representative example is the Reveal LINQ, approved by the FDA in 2014, which weighs 2.5 grams and measures 44 mm × 7 mm × 4 mm, incorporating wireless remote monitoring capabilities via to a and subsequent cellular transmission through the CareLink Network for clinician review.

History and Development

Early Innovations

The concept of an implantable loop recorder (ILR) emerged in the late 1980s as a solution for long-term electrocardiogram (ECG) monitoring to overcome the limitations of short-term external devices in diagnosing infrequent cardiac arrhythmias, particularly in patients with unexplained syncope. The initial prototype, developed by in the early 1990s, was based on a modified platform with surface electrodes for subcutaneous ECG detection, allowing continuous recording without leads. This device, first introduced in 1990, was implanted in the pectoral region and provided up to 14 months of monitoring capability through patient activation during symptoms. A key milestone occurred with the commercial launch of the Reveal ILR in 1999, which received FDA clearance in 1998 as the first dedicated ILR for clinical use. The Reveal enabled patient-activated recording of subcutaneous ECG events, storing up to 42 minutes of data per episode, facilitating correlation between symptoms and rhythm disturbances. Early adoption focused on its role in syncope evaluation, where it offered extended monitoring without the need for transvenous leads. Between 1999 and 2002, initial clinical trials validated the device's efficacy. These trials demonstrated high diagnostic yields through symptom-rhythm correlation in syncope patients, guiding interventions like implantation. Early ILRs faced challenges, including a larger size comparable to credit-card dimensions (approximately 61 mm × 19 mm × 8 mm for the Reveal), which complicated implantation and increased procedural complexity. Battery life was limited to about 14 months, necessitating eventual explantation for replacement. Additionally, the subcutaneous placement and incision requirements contributed to risks, reported in up to 2-4% of cases, often requiring device removal. These limitations spurred iterative improvements in subsequent designs.

Recent Advancements

Since the early 2010s, implantable loop recorders (ILRs) have undergone significant miniaturization and battery life enhancements to improve patient comfort and monitoring duration. In 2014, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance to Medtronic's Reveal LINQ, which is approximately 87% smaller than its predecessor, the Reveal XT, measuring just 1.2 cc in volume and allowing for a less invasive insertion procedure via a 3.9 mm incision. This device also features a battery life of up to three years, extending continuous monitoring capabilities without frequent replacements. Building on this, Medtronic's LINQ II, cleared by the FDA in 2020, incorporates refined arrhythmia detection algorithms, including improved atrial fibrillation (AF) identification and pause detection, which enhance diagnostic accuracy by reducing false alerts. Advancements in (AI) and have further refined ILR performance by enabling precise classification and real-time alerts. In 2021, the FDA cleared Medtronic's AccuRhythm AI algorithms for the LINQ II, utilizing cloud-based trained on over one million ECGs to reduce false AF alerts by up to 50% while maintaining high . This technology was expanded in 2023 to include the original Reveal LINQ, demonstrating sustained improvements in AF detection efficiency. Similarly, Implicity's ILR-ECG Analyzer, cleared by the FDA in 2021, integrates with ILRs to analyze ECG data using AI, reducing false positives by nearly 80% and classifying rhythms with 99% , thereby streamlining clinician workflows. These AI enhancements support , allowing for earlier intervention in management. As of 2025, continued refinements in AI algorithms, such as further reductions in non-actionable alerts, have improved clinical efficiency without major new hardware introductions. Battery longevity reached a new milestone with Abbott's Assert-IQ ICM, which received FDA clearance in and offers up to six years of monitoring—double the duration of prior models—while incorporating advanced algorithms that cut false and pause detections by 98.7%. The device includes an integrated to correlate trends with patient activity levels, providing contextual insights into symptoms like . Broader compatibility has also advanced, with MRI-conditional designs becoming standard since Medtronic's Reveal XT clearance in 2011, minimizing artifact interference during scans at 1.5T and 3T fields. Additionally, since Abbott's Confirm Rx clearance in 2017, ILRs have integrated connectivity with apps, enabling patient-activated recordings and automatic data transmission every 20 seconds for remote clinician access.

Mechanism of Operation

Recording and Detection

The implantable loop recorder (ILR) captures cardiac electrical activity through subcutaneous electrodes integrated into the device housing, forming a single-lead electrocardiogram (ECG) configuration. These electrodes, typically spaced 35-88 mm apart depending on the model, detect far-field subcutaneous signals with a sensing oriented approximately parallel to lead II of a surface ECG, providing a view of the inferior and lateral heart walls. The recorded signal undergoes amplification and filtering, with a common of 0.5-40 Hz to preserve diagnostic morphology while reducing noise, and is digitized at sampling rates ranging from 128 to 256 Hz for adequate of arrhythmias. Detection of arrhythmic events occurs via two primary modes: automatic and patient-activated. In automatic mode, proprietary algorithms continuously analyze the ECG for predefined thresholds, such as heart rates exceeding 175-220 beats per minute for or falling below 30-40 beats per minute for , as well as rhythm irregularities like (AF) episodes lasting at least 6 minutes based on R-R interval variability. Patient-activated mode allows individuals to manually trigger recording by pressing an external activator device during symptomatic episodes, such as or presyncope, capturing the event for later correlation with ECG data. These modes complement each other, with automatic detection capturing asymptomatic events that might otherwise go undocumented. Storage in ILRs employs a continuous loop-overwriting to manage limited onboard , typically accommodating 30-60 minutes of ECG in total. The device perpetually records and cycles through a , discarding older segments unless an event trigger—either automatic or patient-initiated—prioritizes preservation of 20-30 minutes pre-event and 1-5 minutes post-event, ensuring context around the . Detected episodes, such as high-priority , are flagged and protected from overwriting to facilitate clinical review, while less critical segments are replaced to optimize space for ongoing monitoring. Algorithmic processing relies on device-specific software to interpret ECG features, with Medtronic's Reveal system exemplifying advancements through its integration of R-R interval analysis and P-wave detection for enhanced specificity. For instance, the AccuRhythm algorithm incorporates to differentiate supraventricular from ventricular tachycardias, achieving high for while reducing false positives for , with overall accuracy exceeding 98% for confirmed abnormal rhythms in clinical evaluations. As of 2025, newer models incorporate advanced features, such as in the II and Assert-IQ systems, for improved specificity in arrhythmia classification.

Data Management and Transmission

Implantable loop recorders (ILRs) utilize onboard to store electrocardiogram (ECG) data from detected events, typically capturing 1 to per episode depending on the device model and configuration. For instance, the Reveal LINQ system stores up to 59 minutes total, including 27 minutes for patient-triggered events and 32 minutes for automatically detected arrhythmias. Compression algorithms, such as lossless techniques, are employed to optimize storage efficiency by reducing file sizes while preserving signal integrity. Data interrogation occurs primarily in clinical settings using wand-based telemetry, which employs radiofrequency (RF) or inductive coupling to wirelessly retrieve stored ECG recordings from the device. This process allows healthcare providers to download and review episodes without invasive procedures. Remote home monitoring supplements in-clinic interrogations through automatic uploads via cellular networks or connectivity, typically scheduled every 1 to 30 days to transmit summaries to clinicians. Recorded data is exported in formats such as annotated PDF ECG strips, which include tracings, timestamps, and interpretations for easy review. Integration with electronic health records (EHR) is facilitated by proprietary platforms like Medtronic's CareLink Network, enabling seamless data transfer and clinical workflow incorporation. To safeguard patient information, ILR systems incorporate for all data transmissions, ensuring protection against unauthorized access during both in-clinic and remote processes. These security measures align with HIPAA standards, which have mandated since the Security Rule's implementation in 2005.

Clinical Applications

Primary Indications

Implantable loop recorders (ILRs) are primarily indicated for the of recurrent unexplained syncope, especially in cases where initial evaluations, including , , , and , fail to identify a cause, and an arrhythmic is suspected. The 2017 ACC/AHA/HRS Guideline for the and Management of Patients With Syncope provides a Class IIa recommendation (Level of Evidence B-R) for ILR implantation in selected patients with syncope of suspected arrhythmic origin following a nondiagnostic initial , as it offers prolonged to capture infrequent events that shorter-term ambulatory ECG methods may miss. This approach is particularly valuable in patients without structural heart disease, where arrhythmias such as or may underlie the episodes, enabling targeted interventions like implantation. Another key indication is the evaluation of cryptogenic stroke to detect occult atrial fibrillation (AF), which can inform anticoagulation therapy and reduce recurrent stroke risk. The CRYSTAL AF trial (2014), a multicenter randomized controlled study, showed that ILR monitoring detected AF in 8.9% of patients at 6 months and up to 30% at 36 months, compared to only 1.4% and 3.0% with standard care, highlighting the device's superior sensitivity for identifying subclinical AF episodes lasting at least 30 seconds. This detection rate of 10-30% across follow-up periods underscores the ILR's role in this population, where conventional monitoring often underperforms due to the infrequency of AF. ILRs are also recommended for patients experiencing infrequent palpitations or symptoms suggestive of arrhythmias, such as or , that remain undiagnosed after initial noninvasive tests like Holter monitoring or event recorders. In these scenarios, the device's long-term continuous recording capability—up to 3 years—allows capture of rare events that correlate symptoms with rhythm disturbances, guiding decisions on antiarrhythmic therapy or .

Emerging Uses

Implantable loop recorders (ILRs) have expanded beyond traditional diagnostic roles to monitor (AF) recurrence following procedures. In patients undergoing ablation for paroxysmal AF, continuous ILR monitoring detects recurrence rates of approximately 47% at 12 months, compared to only 27% identified through symptom-based confirmation, indicating that standard intermittent methods miss nearly half of all episodes. A systematic review of ablation trials further confirms that ILRs reveal higher recurrence rates (46.9%) versus intermittent monitoring (31.2%) in paroxysmal AF cases, underestimating detections by up to 15.7%. These findings, drawn from studies like those employing devices such as the Reveal XT, highlight ILRs' role in capturing recurrences, enabling more precise assessment and timely intervention. In heart failure management, ILRs facilitate the correlation of subclinical arrhythmias with disease , guiding targeted therapies to mitigate progression. The CARRYING ON pilot study found that 72% of patients experienced major cardiovascular events following acute decompensation, with arrhythmias present in over half of those cases, underscoring ILRs' utility in identifying rhythm disturbances that precede worsening symptoms. Recent evaluations, including those from the LINQ2-HF trial protocol, emphasize continuous ILR monitoring in reduced patients to detect asymptomatic and other arrhythmias, potentially informing adjustments in anticoagulation or pacing strategies to prevent exacerbations. Although direct reductions in hospitalizations vary, ILR-enabled arrhythmia screening has been associated with lower rates of events and cardiovascular mortality in observational data. ILRs are increasingly applied to evaluate autonomic dysfunction in syndromes, particularly for detecting nocturnal and pauses that overlap with respiratory events. In patients with obstructive sleep apnea-hypopnea syndrome (OSAHS), insertable loop recorders have documented severe bradyarrhythmias, including pauses exceeding 3 seconds and heart rates below 30 beats per minute, occurring predominantly during apneic episodes due to vagal surges. Continuous ILR monitoring in this population reveals a high incidence of such events, with (CPAP) therapy reducing bradyarrhythmia and pause frequency by up to 50% in treated cohorts. This approach aids in distinguishing benign sleep-related rhythms from those warranting intervention, such as implantation, in overlap syndromes involving cardiovascular risk. Pediatric applications of ILRs remain limited but are evolving for congenital rhythm disorders, supported by recent regulatory expansions for smaller devices. The Medtronic LINQ II, measuring one-third the size of an AAA battery (approximately 0.6 grams), received FDA 510(k) clearance in 2022 for use in children aged 2 years and older with suspected arrhythmias, broadening access for long-term monitoring in this vulnerable group. In congenital heart disease, ILRs provide safe, effective of infrequent arrhythmias, offering reassurance to families and guiding management without invasive alternatives, though implantation is reserved for cases where noninvasive methods fail. Studies report high diagnostic yield and low complication rates in pediatric cohorts, with devices supporting up to 4.5 years of monitoring for disorders like or pauses.

Implantation and Management

Procedure Details

The implantation of an implantable loop recorder (ILR) begins with comprehensive preoperative preparation to ensure patient safety and optimal outcomes. Patients undergo discussions, where risks, benefits, and procedural details are explained, including how the device will be activated post-implantation through simple patient-initiated actions such as passing a over the site. Preoperative evaluation may include prophylaxis in high-risk patients (e.g., those with ), per local guidelines, to minimize risk. Patient education emphasizes device activation and basic wound care instructions prior to the procedure. The surgical technique is minimally invasive and performed under , with no general required, allowing the patient to remain awake and comfortable. A small 1-2 cm incision is made in the left infraclavicular area, typically at the level of the second or third , just lateral to the . Using sterile technique, a shallow subcutaneous pocket is created just under the skin through blunt to accommodate , ensuring proper orientation for optimal signal detection. The ILR is then inserted into the pocket, and intraoperative testing is conducted to verify signal quality and sensing thresholds, often using the device connected to ECG monitoring. may be employed briefly to confirm precise positioning, particularly in cases requiring enhanced visualization. This outpatient procedure, typically conducted by an electrophysiologist or cardiologist in a sterile treatment room or electrophysiology lab equipped with resuscitation capabilities, lasts 15-30 minutes from incision to closure. The incision is closed with absorbable sutures, and a sterile dressing is applied, completing the immediate post-implantation phase. Follow-up monitoring begins shortly after to ensure device functionality.

Post-Procedure Care

Following implantation of an (ILR), patients typically return home the same day, accompanied by a responsible adult for transportation, with pain managed using over-the-counter medications such as acetaminophen or ibuprofen if needed. A sterile dressing is applied over the incision site and should remain in place for 24 to 48 hours to minimize infection risk, after which it can be removed; the wound must be kept clean and dry, with showering permitted using a waterproof cover but no soaking in baths or pools for at least one week. Patients are advised to limit strenuous activities, such as heavy lifting or vigorous exercise, for about one week to allow proper healing, while resuming normal daily routines otherwise. Patients receive detailed instructions on device management, including how to manually activate recording during symptomatic episodes such as , , or syncope by pressing a button on a provided handheld activator or , which captures and stores electrocardiographic data for later review. For devices with remote monitoring capabilities, patients may use a dedicated or bedside transmitter to facilitate automatic data transmission to the healthcare team, enabling alerts for detected arrhythmias without requiring in-person visits. Follow-up care generally includes an initial wound check or clinic visit within 1 to 2 weeks post-implantation, followed by periodic interrogations every 3 to 6 months or as needed based on remote data, to assess device function and review recordings. Explantation of the ILR is typically elective and performed once the diagnostic purpose is fulfilled or at the end of the device's battery life, which generally lasts 2 to 3 years depending on the model and monitoring frequency. The removal procedure is similar to implantation, conducted as an outpatient under with a small incision over the existing to extract the device, allowing for same-day . Battery end-of-life is monitored remotely, with indicators such as reduced recording capacity or alerts prompting evaluation for replacement or removal. For lifestyle integration, patients should carry an identification card detailing the device to inform security personnel at or similar venues, as it may trigger metal detectors. Most ILRs are MR conditional, permitting (MRI) scans under specific conditions such as field strength limits (typically 1.5T or 3T) and device if necessary, but patients must consult their cardiologist beforehand to evaluate risks like temporary sensing interference. Strong magnets, such as those in MRI machines or certain industrial tools, should be avoided, as they can activate the device's , potentially suspending monitoring or erasing stored data.

Risks and Complications

Common Issues

Local pain and discomfort at the implantation site is a frequent issue following insertion of an implantable loop recorder, typically resolving within 1-4 weeks. This symptom arises from tissue trauma during the subcutaneous placement procedure and is generally managed with nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. Pocket , characterized by blood accumulation in the device pocket, occurs in less than 2% of cases for ILRs and is often self-limiting, though intervention such as may be necessary if the hematoma exceeds 2 cm in size. Risk factors include anticoagulation or antiplatelet , which can exacerbate bleeding at the site. Skin erosion, where the device protrudes through the overlying skin, has a reported rate of 0.6-4.7% and is more prevalent in patients with thin , such as the elderly or those with low body mass. This complication is frequently associated with device migration. Infection at the implantation site carries a risk of 0.5-2% and is most commonly caused by species, presenting as localized , warmth, or swelling typically within the first month post-procedure. Early recognition is crucial, as untreated infections can lead to device removal. Overall complication rates for ILRs are low, typically under 5%, with major adverse events occurring in less than 1% of cases based on recent studies as of 2025. While rare severe outcomes such as systemic or significant device malfunction can occur, they represent a small fraction of total adverse events.

Management Strategies

Management of implantable loop recorder (ILR) complications focuses on conservative approaches for minor issues and escalation for severe ones. Pain is typically addressed with NSAIDs and local care, while hematomas may require or if symptomatic. Infections demand prompt antibiotics tailored to cultures, and or often necessitates surgical repositioning or removal. Remote monitoring aids in early detection, reducing the need for invasive interventions.

Prevention

Preventive measures for complications associated with implantable loop recorders (ILRs) emphasize meticulous procedural techniques and patient optimization. Strict adherence to sterile and aseptic techniques during implantation is essential to minimize infection risk, as procedural contamination is a primary factor in device-related infections. Perioperative antibiotic prophylaxis, such as intravenous cefazolin, is commonly administered prior to incision in many centers to target skin flora, though evidence for routine use in low-risk ILR procedures remains limited and is often reserved for high-risk patients like those with diabetes or immunosuppression. Careful patient selection plays a key role, with clinicians advised to weigh benefits against risks in immunocompromised individuals, where infection susceptibility may be heightened, potentially deferring implantation if alternatives exist. To address potential device migration, follow-up imaging such as chest X-ray is recommended if symptoms like pain or signal loss suggest displacement, enabling early detection and intervention.

Diagnosis

Diagnosing ILR complications involves targeted clinical and diagnostic tools to identify issues promptly. For suspected pocket hematomas, ultrasound imaging provides a non-invasive means to assess fluid collections and guide management decisions. Infections are evaluated through swabs from the incision site or device pocket, allowing identification of pathogens and appropriate tailoring of . Device malfunctions, including low alerts or signal loss, are monitored via remote electrocardiogram (ECG) transmissions during routine follow-ups, which facilitate early detection of technical issues without requiring in-person visits.

Treatment Options

Treatment of ILR complications is tailored to the specific issue, often combining medical and surgical approaches. Superficial infections are initially managed with targeted antibiotics, such as for (MRSA) cases, guided by culture results to ensure pathogen coverage. For device erosion or persistent infections, surgical revision is indicated, with complete explantation required in less than 1% of cases overall. Chronic post-implantation pain, particularly neuropathic in nature, may be alleviated with medications such as as an , helping to reduce discomfort in select patients.

Long-Term Monitoring

Ongoing surveillance is critical to balance ILR benefits against emerging s. Annual assessments, incorporating clinical reviews and remote , help evaluate device performance and patient status. According to 2021 ESC guidelines and the 2023 HRS/EHRA/APHRS/LAHRS expert consensus, early explantation should be considered if complications outweigh diagnostic yield, such as in cases of recurrent infections or migration, to mitigate long-term morbidity.

References

  1. [1]
    Implantable loop recorder: A heart monitoring device - Mayo Clinic
    Mar 4, 2025 · An implantable loop recorder is a very small device that continuously checks the heartbeat. It stays in place under the skin of the chest for up to three years.Missing: function | Show results with:function
  2. [2]
    Implantable Loop Recorder - StatPearls - NCBI Bookshelf - NIH
    The implantable loop recorder (ILR) is a subcutaneous monitoring device used to monitor electrical activity of the heart over an extended period.Missing: function | Show results with:function
  3. [3]
    Cardiac Event Recorder - American Heart Association
    Oct 10, 2024 · An implantable loop recorder is implanted under the skin on the chest and can be left in place for three or more years. These devices can send ...Missing: definition | Show results with:definition
  4. [4]
    Implantable loop recorder in clinical practice - PMC - NIH
    The implantable loop recorder (ILR), also known as insertable cardiac monitor (ICM) is a subcutaneous device used for diagnosing heart rhythm disorders.
  5. [5]
    Loop Recorder Implantation | Johns Hopkins Medicine
    An implantable loop recorder, or ILR, is a device that helps the heart. It has several uses. The most common ones include looking for causes of fainting, ...
  6. [6]
    510(k) Premarket Notification - FDA
    510(k) Premarket Notification ; Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) · K972242 · REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM.
  7. [7]
    Holter Monitoring and Loop Recorders: From Research to Clinical ...
    Table 2: Technical Characteristics of the Reveal XT and Newer-generation Reveal LINQ Implantable Loop Recorders. ... Weight (g), 2.5, 15. Volume (mL), 1.2, 9.Missing: size | Show results with:size
  8. [8]
    https://pmc.ncbi.nlm.nih.gov/articles/PMC5013174/
  9. [9]
    K132649 - 510(k) Premarket Notification - FDA
    REVEAL LINQ INSERTABLE CARDIAC MONITOR. Applicant. MEDTRONIC INC. 8200 Coral ... Date Received, 08/26/2013. Decision Date, 02/14/2014. Decision, Substantially ...
  10. [10]
    [PDF] 510(k) SUMMARY - accessdata.fda.gov
    The Medtronic Model 9525 Reveal Insertable Loop Recorder is an implantable, patient- activated monitoring system that records subcutaneous ECG and is designed ...Missing: 2002 | Show results with:2002
  11. [11]
    Use of an extended monitoring strategy in patients with ... - PubMed
    The strategy of prolonged monitoring is effective and safe in patients with problematic syncope.
  12. [12]
    [PDF] July 3, 2020 Medtronic, Inc. Eric Kalmes Sr. Principal Regulatory ...
    Jul 3, 2020 · The LINQ II ICM is substantially equivalent to the predicate device, the existing Reveal LINQ ICM (cleared by FDA under K162855) based on.Missing: K972242 | Show results with:K972242<|control11|><|separator|>
  13. [13]
    Medtronic Announces FDA Clearance and Results of Artificial ...
    Jul 28, 2021 · AI Algorithms Enhance LINQ II™ Insertable Cardiac Monitor Diagnostic Accuracy for Improved Management of Patients.
  14. [14]
    Medtronic AccuRhythm AI technology receives 2023 MedTech ...
    May 16, 2023 · AccuRhythm AI algorithms now cleared by FDA for the Reveal LINQ ICM; enhancements made to the AF algorithm for the LINQ II ICM.
  15. [15]
    FDA Clears AI-Powered ECG Analyzer for Implantable Loop ...
    Implicity received US Food and Drug Administration (FDA) clearance for a novel medical algorithm that analyzes ECG data from implantable loop recorders (ILRs).
  16. [16]
    Abbott Receives FDA Clearance for Assert-IQ™ Insertable Cardiac ...
    May 18, 2023 · The Assert-IQ ICM is intended to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac ...
  17. [17]
    [PDF] Assert-IQ™ Insertable Cardiac Monitor (ICM) - Abbott Cardiovascular
    Activity trend data demonstrated elevated heart rate without physical activity, exceeding 4 hours daily throughout the month of January.Missing: dual- | Show results with:dual-
  18. [18]
    [PDF] 510(k) Summary - accessdata.fda.gov
    Apr 1, 2011 · The Reveal XT 1CM Model 9529 and Reveal DX Model 9528 are small, leadless devices that are typically implanted under the skin, in the chest. Two ...Missing: loop | Show results with:loop
  19. [19]
    K163407 - 510(k) Premarket Notification - FDA
    Sep 29, 2017 · 510(k) Premarket Notification ; Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) · K163407 · Confirm Rx Insertable Cardiac ...Missing: Abbott machine learning
  20. [20]
    Factors affecting signal quality in implantable cardiac monitors with ...
    The provided sECG has a sampling rate of 128 Hz and an 8‐bit amplitude resolution. ... Indications for the use of diagnostic implantable and external ECG loop ...
  21. [21]
    Subcutaneouscardiac Rhythm Monitors: A Comprehensive Review
    Subcutaneous loop recorders (SCRMs) are subcutaneous electronic devices which have revolutionized the field of arrhythmia detection.Evolution Of Scrms · Implant Considerations · Scrms For Unexplained...
  22. [22]
    PO-04-085 FAILED LOOP RECORDER WOUND CLOSURE DUE ...
    The most common implant technique involves a parasternal incision along the 3rd or 4th intercostal space. ... vector similar to lead II of an ECG. Excellent ...Missing: implantable | Show results with:implantable
  23. [23]
    Indications for the use of diagnostic implantable and external ECG ...
    May 1, 2009 · Finally, reduction in device size and weight would simplify the implant procedure and would increase patient and physician's acceptance. Device ...
  24. [24]
    AT/AF Episode Detection - ICM Feature - Medtronic Academy
    There are several programmable options for AT/AF Recording Threshold: All episodes; Episodes ≥ 6, 10, 20, 30 or 60 mins; Only Longest Episode (≥ 10 min). If AT/ ...
  25. [25]
    Comparison of automatic and patient-activated arrhythmia ... - PubMed
    Second generation ILRs have the ability to record events either automatically (auto activated) or by manual activation (patient activated). In an attempt to ...Missing: modes | Show results with:modes
  26. [26]
    Effect of Implantable vs Prolonged External Electrocardiographic ...
    Jun 1, 2021 · The minimum duration of irregular rhythm that the implantable loop recorder will store as AF is 2 minutes, therefore this duration was chosen ...Missing: capacity overwriting pre
  27. [27]
    Implantable loop recorders for assessment of syncope: is 'Saint ...
    Two ECG signal storage modes were allowed: (i) a 21 min mode capturing a single event with an ECG recording lasting from 20 min before to 1 min after activation ...
  28. [28]
    Accuracy of implantable loop recorders for detecting atrial ...
    Apr 24, 2020 · The main findings of this study were that the sensitivity of the ILR in detecting AF was 81.6% for the Medtronic Reveal XT™. However, the ...
  29. [29]
    Reveal LINQ™ Insertable Cardiac Monitor - Medtronic
    The Reveal LINQ™ ICM with AccuRhythm™ AI algorithms is for patients with infrequent symptoms requiring long-term cardiac monitoring.
  30. [30]
    Clinical impact, safety, and accuracy of the remotely monitored ...
    Jul 24, 2017 · Aims. Implantable loop recorders (ILR) are indicated in a variety of clinical situations when extended cardiac rhythm monitoring is needed.
  31. [31]
    Improved diagnostic performance of insertable cardiac monitors by ...
    Jan 3, 2024 · The ILR-ECG-A retained a high sensitivity of 98.6% in detecting abnormal episodes, which makes it a reliable diagnostic tool for arrhythmias, ...
  32. [32]
    [PDF] 001_Reveal LINQ Mobile Manager for iOS mobile devices
    May 26, 2016 · The implantable device memory can store up to 27 min of. ECG ... patient connector Model 24965 to the Reveal LINQ ICM with the existing Reveal ...
  33. [33]
    Medtronic LINQ Family of ICMs: Reveal LINQ and LINQ II Comparison
    Episode storage, 59 min, 61 min ; Monitoring option, Home monitor, Home monitor and mobile app ; Patient symptom mark ...Product Comparison: Reveal... · Brief Statements · Medtronic Linq Family...
  34. [34]
    Implantable ICM Loop Recorder for dogs - Dextronix
    The BIOvector provides high signal amplitudes; the fractal coating increases the sensing surface area, and the unique lossless compression algorithm enhances ...
  35. [35]
    [PDF] Remote monitoring of patients with cardiovascular implantable ...
    Nov 9, 2021 · through an inductive programming wand or using RF signals. However, some ILR devices do offer the capability of remote programming as these.
  36. [36]
    Remote monitoring of cardiac implantable electronic devices and ...
    Aug 25, 2023 · An advance in CIED-based inductive technology allowed for remote interrogation (RI) through wand-based radiofrequency data transfer, in a ...
  37. [37]
    MyCareLink Heart App - Remote Monitoring - Medtronic
    Medtronic heart devices enabled with Bluetooth can communicate directly with the MyCareLink Heart mobile app on your smartphone or tablet.
  38. [38]
    Remote Monitoring for Implantable Loop Recorder (ILR) - UW Health
    The transmitter will create a summary report every month and send it to us at the clinic, so that your doctor can assess your heart rhythm.Missing: cellular | Show results with:cellular
  39. [39]
    Implantable Loop Recorder Monitoring - EquiMed Corporation
    All implantable loop recorders must be monitored continuously and a review of all transmissions must be done at least one time per 30 day period (12 times per ...Missing: frequency | Show results with:frequency
  40. [40]
    AI Filter Improves Positive Predictive Value of Atrial Fibrillation ...
    The purpose of this study was to determine whether incorporation of a 2-part artificial intelligence (AI) filter can improve the positive predictive value (PPV)New Research Paper · Dnn Filter For Af Detection · Discussion
  41. [41]
    CareLink Network - Reveal LINQ ICM - Medtronic
    The CareLink Network provides efficient patient management and clinically actionable reports for the Reveal LINQ Insertable Cardiac Monitor.Missing: EHR | Show results with:EHR
  42. [42]
    [PDF] Technical Safeguards - HIPAA Security Series #4 - HHS.gov
    There are many different encryption methods and technologies to protect data from being accessed and viewed by unauthorized users. Sample questions for ...Missing: ILR | Show results with:ILR
  43. [43]
    2017 ACC/AHA/HRS Guideline for the Evaluation and Management ...
    Additional Evaluation and Diagnosis for Syncope. Colors correspond to Class of Recommendation in Table 1. *Applies to patients after a normal initial evaluation ...
  44. [44]
    2017 ACC/AHA/HRS Guideline for the Evaluation and Management ...
    To provide guidance and recommendations on the evaluation and management of patients with suspected syncope in the context of different clinical settings, ...
  45. [45]
    Cryptogenic Stroke and Underlying Atrial Fibrillation
    Jun 26, 2014 · The rate of detection of atrial fibrillation at 6 months was 8.9% among patients assigned to the ICM group (19 patients), as compared with 1.4% ...
  46. [46]
    https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/administrative/securityrule/techsafeguards.pdf
  47. [47]
    Global Results of Implantable Loop Recorder for Detection of Atrial ...
    Oct 25, 2024 · Long‐term rhythm monitoring using ILR was described as reasonable to improve AF detection for patients with stroke or TIA in recent US ...
  48. [48]
    Continuous Monitoring with Implantable Loop Recorders After ... - NIH
    Apr 24, 2025 · Continuous monitoring with implantable loop recorders (ILRs) has transformed post-ablation follow-up by providing comprehensive, long-term ...
  49. [49]
    Rhythm-Monitoring Strategy and Arrhythmia Recurrence in Atrial ...
    The rhythm-monitoring strategy after catheter ablation (CA) for atrial fibrillation (AF) impacts the detection of atrial arrhythmia recurrence and is not well ...
  50. [50]
    Monitoring Atrial Fibrillation After Catheter Ablation - PMC - NIH
    External loop recorder systems are ideal for capturing also asymptomatic AF recurrences; the ECG recording is triggered either automatically, according to ...Missing: EAST- AFNET
  51. [51]
    Cardiac Rhythm Monitoring After Acute Decompensation for Heart ...
    Apr 26, 2016 · The CARdiac RhYthm monitorING after acute decompensatiON for Heart Failure study was designed to assess the incidence of prespecified clinical ...Missing: correlation | Show results with:correlation
  52. [52]
    The LINQ2-HF trial rationale and protocol | PLOS One
    Evaluation of continuous arrhythmia monitoring using an implantable loop recorder in heart failure patients with a reduced ejection fraction: The LINQ2-HF trial ...
  53. [53]
    Implantable cardiac monitor in heart failure: just a toy or a useful tool?
    Feb 19, 2025 · In any case, case-control studies are needed to establish whether this tool can be truly useful in HF. Keywords: Heart failure, Remote ...
  54. [54]
    Severe bradyarrhythmias in patients with sleep apnoea: the effect of ...
    It is well known that patients with OSAHS, apart from showing a higher incidence of cardiovascular disorders, also often suffer from cardiac rhythm disturbances ...
  55. [55]
    Sleep-Disordered Breathing and Cardiac Arrhythmias in Adults
    Aug 1, 2022 · ... bradycardia or conduction disorder during sleep ... Sleep apnea and atrial fibrillation: role of the cardiac autonomic nervous system.
  56. [56]
    Severe bradyarrhythmias in patients with sleep apnoea: the effect of ...
    In all patients, an insertable loop recorder capable of monitoring the heart rhythm for 16 months was implanted. Cardiac pauses >3 s and bradycardic episodes < ...Missing: detection overlap
  57. [57]
    Medtronic receives FDA clearance for expanded indication of LINQ II ...
    Sep 20, 2022 · Medtronic receives FDA clearance for expanded indication of LINQ II™ insertable cardiac monitor for use in pediatric patients ages 2 and older.
  58. [58]
    Implantable loop recorder for monitoring patients with congenital ...
    ILR implantation should be considered in patients with CHD of any complexity who need medium or long-term arrhythmia monitoring.
  59. [59]
    Role of new generation implantable loop recorders in managing ...
    Aug 19, 2024 · An ILR system consists of three main components: the loop recorder itself, an external device to manually activate recordings during ...
  60. [60]
    [PDF] Standards for insertion, follow up and explant of implantable loop ...
    A IIa recommendation is given for ILR implantation for patients with suspected or certain reflex syncope presenting with frequent or severe syncopal episodes (2) ...
  61. [61]
    Implantable Loop Recorder (ILR) - Cleveland Clinic
    An implantable loop recorder is a small device placed in your chest, just under the skin, to monitor your heart. It finds arrhythmias that other tests ...
  62. [62]
    About Your Implantable Loop Recorder
    May 5, 2023 · What to do while you have an ILR. Leave the bandage over your incision for 2 to 3 days. After 2 to 3 days, you can take the bandage off and ...What is an implantable loop... · Why may you need an... · What to do before the...
  63. [63]
    Implantable Loop Recorder (ILR) | Patients & Families - UW Health
    You may shower after 24 hours. Keep the incision clean and pat dry after showering.Missing: guidelines | Show results with:guidelines
  64. [64]
    [PDF] Caring for Your Internal Loop Recorder (ILR) - Health Online
    If your wound is closed with a skin glue: – You may shower 48 hours after your surgery. – Do not soak your incision until it is fully healed.Missing: guidelines | Show results with:guidelines
  65. [65]
    https://patient.uwhealth.org/healthfacts/7475
  66. [66]
    Safety of Magnetic Resonance Imaging in Patients With ...
    Nov 19, 2007 · The Reveal Plus ILR has been labeled as “MR conditional.” Patients with a Reveal Plus ILR can undergo MR examination any time after implantation ...General Safety... · Hemodynamic Monitoring And... · Permanent Cardiac Pacemakers...
  67. [67]
    Feasibility of Magnetic Resonance Imaging in Patients with an ...
    Feb 28, 2008 · MRI scanning of ILR patients can be performed without harm to patient or device, but artifacts that could be mistaken for a tachyarrhythmia are seen frequently.Missing: explantation compatibility
  68. [68]
    Effects of External Electrical and Magnetic Fields on Pacemakers ...
    Schedule follow-up interrogation in 3–6 months. Open in a new tab. It is important to note that MRI in the setting of standard CIEDs is performed off-label ...
  69. [69]
    Magnetic Resonance Imaging and Implantable Devices | Circulation
    Apr 1, 2013 · Patients with an implantable loop recorder can be safely scanned. However, the device may record MRI EMI artifacts as arrhythmia. Care should be ...
  70. [70]
    Adverse events of subcutaneous loop recorders - PubMed
    Patient adverse events were reported 1,030 times. Pain or discomfort (n = 275, 26.70%), site infection (n = 213, 20.68%), erosion (n = 138, 13.40%), ...
  71. [71]
    Risk of Hematoma Complications After Device Implant in the ...
    Previous reports show an occurrence of pocket hematoma formation of 2% to 5%. A variety of antiplatelet and anticoagulant drugs are routinely used in the ...
  72. [72]
    Un-LINQed: Spontaneous extrusion of newer generation ... - PubMed
    Apr 13, 2020 · Conclusions: Device migration and erosion through skin are important potential adverse events for the Reveal LINQ implantable loop recorder.
  73. [73]
    Migration of Implantable Loop Recorders - EMRA
    Feb 12, 2022 · While complications of implantable loop recorders are rare, devices can be subject to migration and erosion through the skin into the cardiac or pleural space.
  74. [74]
    Postoperative Antibiotic Prophylaxis Following Cardiac Implantable ...
    The reported incidence of CIED infection varies from less than 1% to more than 7%, with more recent research suggesting rates of 0.5% to 2.2%. As the ...