Medtronic 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 offers a variety of solutions to address many disease states, including a broad cardiovascular portfolio that features innovative devices, such as the LINQ II™ ICM. The world's most accurate implantable cardiac monitoring device,^1-4 the LINQ II ICM is personalized for the patient's lifestyle and customized for the clinician's workflow. Click here to request information about Medtronic cardiac devices, such as the Reveal LINQ™ and LINQ II ICM.

Learn more about how Medtronic is taking healthcare Further, Together at Medtronic.com.

economic evidence

Do implantable loop recorders impact the survival of patients with recurrent unexplained syncope?

This Medtronic sponsored analysis used data from a large German claims database to determine whether monitoring syncope patients with implantable loop recorders (insertable cardiac monitors or ICMs) could impact outcomes from the German healthcare perspective. Read more. 

Cost–effectiveness of an insertable cardiac monitor to detect atrial fibrillation in patients with cryptogenic stroke

This Medtronic-sponsored study, published in the Journal of Comparative Effectiveness Research, assesses cost-effectiveness of insertable cardiac monitors in a U.S. cryptogenic stroke population. The findings show that using an ICM first after a cryptogenic strokes leads to overall average lower per-patient costs, and a modest improvement in QALYs, compared to starting with an external short-term monitor of any duration and then progressing to an ICM. Read more. 

Economic evaluation of extended electrocardiogram monitoring for atrial fibrillation in patients with cryptogenic stroke

This cost-utility analysis, published in the International Journal of Stroke, compares three ECG monitoring strategies for the detection of occult paroxysmal AF in patients surviving a transient ischemic attack or cryptogenic stroke in Canada. It concludes that the ICM strategy is more economically attractive than 30-day electrocardiography monitoring compared to conventional monitoring, and is associated with a cost per quality-adjusted life year gained in the range of other publicly funded therapies. The value proposition is improved when considering patients at the highest risk of recurrent ischemic stroke. Read more.  

Clinic time required for remote and in-person management of cardiac device patients: Time and motion workflow evaluation

This Deloitte and Medtronic international workflow evaluation is the first published study to provide a detailed step-by-step characterization of the clinic staff time required to manage CIED patients and may be relevant to device clinicians/administrators in planning for staff needs or optimizing clinic operations. Read more. 

Burden of oral anticoagulation in embolic stroke of undetermined source without atrial fibrillation

This Medtronic-sponsored analysis modeled the economic impact of empiric oral anticoagulation in ESUS patients who do not have AF after long-term monitoring with an ICM. Results showed that OAC use in non-AF patients would be substantially cost-additive, driven by the cost of bleeding events and drug costs. These findings reinforce the results of the NAVIGATE and RESPECT ESUS trials and support the personalized approach of monitoring for AF and treating accordingly. Read more.

Economic value of insertable cardiac monitors in unexplained syncope in the United States

This cost-effectiveness analysis, published in BMJ Open Heart, assesses the cost-effectiveness of ICMs compared with standard of care diagnostic testing for unexplained syncope patients in the U.S. Analysis found that use of ICMs led to significant lifetime cost-savings, driven by earlier arrhythmia diagnosis and therapeutic intervention. Read more.

CLINICAL EVIDENCE

STROKE AF

The Medtronic-sponsored STROKE AF randomized controlled trial determined whether long-term cardiac monitoring with a Reveal LINQ insertable cardiac monitor (ICM) was superior to usual care for AF detection in patients with stroke attributed to large or small vessel disease (a population usually not considered at high risk for AF). Results showed that ICM patients had significantly higher detection of AF at 12 months versus the control group. Read more.

PER DIEM

The results from this investigator-initiated trial (partially funded by Medtronic) compared 12 months of ICM monitoring with 30-day external loop recorders in patients with a recent ischemic stroke, including all subtypes, and showed significantly higher AF detection in the ICM group. These results corroborate the results from STROKE AF, published in the same number in JAMA. Read more.

2021 Guideline for the Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack: A Guideline from the American Heart Association/American Stroke Association

In May, the AHA/ASA published updated secondary stroke prevention guidelines, which include a Class IIa recommendation for ICM as reasonable to detect intermittent AF. The guidelines also include recommendations that support the need for multidisciplinary care and recommend against empiric anticoagulation in ESUS patients. Read more.

BRIEF STATEMENT FOR MEDTRONIC LINQ FAMILY INSERTABLE CARDIAC MONITOR SYSTEM (ICM) AND REMOTE MONITORING

Indications

The LINQ Family of Insertable Cardiac Monitors (ICMs) which includes Reveal LINQ ICM and LINQ II ICM are insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

• patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

These devices have not been tested specifically for pediatric use.

Contraindications

There are no known contraindications for the insertion of the LINQ Family ICM’s or their accessories. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Warnings and Precautions

Patients with a LINQ Family ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical procedure and EMI Warnings, Precautions and Guidance Manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the LINQ II or Reveal LINQ ICM MRI Technical Manual.

Wireless accessories available for use with a LINQ Family ICM may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.

Potential Adverse Events

Potential adverse events from the LINQ Family ICM include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.

There are no known adverse events associated with the use of any LINQ Family ICM wireless accessories.

See the device manuals for detailed information regarding the implant procedure, indications / intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at (800) 328-2518 (Technical Services), (800) 551-5544 (Patient Services), and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts prescription devices to sale by or on the order of a physician.

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 1, 2018;20(FI_3):f321-f328.
2. Confirm Rx™ ICM DM3500 FDA Clearance Letter. 2017.
3. 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.
4. BIOTRONIK BioMonitor 2 Technical Manual. 2017.