Illustration of blue electric heart next to Reveal LINQ™ ICM with aECG strip running through it surrounded by blue particles

Cardiac diagnostics and monitoring

PICTURE study

A study of Reveal™ insertable cardiac monitors (ICM) use in unexplained syncope patients

Indications, Safety, and WarningsBrief statement for Reveal LINQ™ insertable cardiac monitor (ICM) system and accessoriesIndicationsThe Reveal LINQ™ insertable cardiac monitor (ICM) is an implantable patient-activated and automatically-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.

The device has not been tested specifically for pediatric use.ContraindicationsThere are no known contraindications for the implant of the Reveal LINQ™ ICM or its accessories. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.Warnings and precautionsPatients with the Reveal LINQ™ 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 precautions manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ™ MRI technical manual. Accessories available for use with Reveal LINQ™ ICM may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.Potential adverse events or potential complicationsPotential complications of the Reveal LINQ device 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 Reveal LINQ™ ICM accessory.See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at (800) 328-2518 (Technical Services) or (800) 551-5544 (Patient Services).Caution: Federal law (United States) restricts prescription devices to sale by or on the order of a physician.MAJ_90968

The PICTURE study¹

Reveal™ ICMs guide diagnosis in 78% of patients with a recurrent syncopal event.

The PICTURE study investigated the effectiveness of Reveal™ ICMs in the diagnosis of unexplained, recurrent syncope in everyday clinical practice, and helped inform current syncope guidelines.²

Study design¹

570 patients analyzed
Patient eligibility: enrolled patients had recurrent unexplained syncope or pre-syncope
Patients received a Reveal™ ICM
Patients were followed up until the first syncopal recurrence, or for at least one year

Key findings¹

570 patients enrolled

38%

of patients experienced a recurrence within one year.

218 patients

78%

of patients had a Reveal™ ICM-guided diagnosis.¹

170 patients

75%

of patients were diagnosed with a cardiac cause.

128 patients

25%

of patients were confirmed to have a noncardiac issue.

42 patients

Physician specialists consulted before ICM insertion

Clinical impact¹

PICTURE study found that syncope patients:

Moved from specialist to specialist without answers
Had a median of 13 inconclusive tests before a Reveal™ ICM was implanted
70% were hospitalized at least once for syncope and of that, one third experienced significant trauma

By using ICMs earlier in the care pathway, there is the potential to reduce the number of physicians patients see.

Study conclusion¹

ICMs should be implanted earlier rather than later in the evaluation of unexplained syncope.

Related products

Edvardsson N, Frykman V, van Mechelen R, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Europace. 2011;13(2):262–269. doi: 10.1093/europace/euq418.
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. doi: 10.1093/eurheartj/ehy037.

You are leaving the Medtronic Europe site

You just clicked a link to go to another website. If you continue, you may go to a site run by someone else.

We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. Your use of the other site is subject to the terms of use and privacy statement on that site.

It is possible that some of the products on the other site are not approved in your region or country.

First Name

Last Name

EMAIL

Hospital Or Organization

Job Role

Specialty

Confirm country/region

OR

Confirm country/region

Confirm country/region

Confirm country/region

Before we get started, what best describes you?

OR

Confirm country/region

Before we get started, what best describes you?

OR

First Name

Last Name

EMAIL

Hospital Or Organization

HOSPITAL POSTAL CODE

Job Role

Specialty

First Name

Last Name

EMAIL

PHONE

Hospital Or Organization

HOSPITAL POSTAL CODE

Job Role

Specialty

First Name

Last Name

EMAIL

PHONE

Hospital Or Organization

COUNTRY

HOSPITAL POSTAL CODE

Job Role

Specialty

First Name

Last Name

EMAIL

Hospital Or Organization

Country

HOSPITAL POSTAL CODE

Job Role

Specialty

First Name

Last Name

Title

STATE / PROVINCE

EMAIL

PHONE

Hospital Or Practice

Job Role

Specialty

About the latest products, technologies and services:

Yes No

About educational and clinical information (e.g., Medtronic Academy):

Yes No

Would you like to receive the Medtronic customer experience survey?

Yes No

Your information will be processed and protected in accordance with our privacy notice.

Selecting “no” to marketing emails above will not affect your other email selections, and a Medtronic representative will still reach out via email, if selected. Your personal data will used to manage your relationship with Medtronic, and, if you consent, to provide you with relevant email updates based on your user preferences. You can opt-out of receiving such emails at any time by clicking the unsubscribe link in the relevant email. Medtronic may use pixels and other technologies in emails to gather statistics around email opening and clicks, to help us improve our communications and to provide you with relevant content.

For more information, see the {link}

You can always change your preferences or update your personal details by visiting the {link}

First Name

Last Name

Title

STATE / PROVINCE

EMAIL

PHONE

Hospital Or Practice

Job Role

Specialty

About the latest products, technologies and services:

Yes No

About educational and clinical information (e.g., Medtronic Academy):

Yes No

Would you like to receive the Medtronic customer experience survey?

Yes No

Your information will be processed and protected in accordance with our privacy notice.

Selecting “no” to marketing emails above will not affect your other email selections, and a Medtronic representative will still reach out via email, if selected. Your personal data will used to manage your relationship with Medtronic, and, if you consent, to provide you with relevant email updates based on your user preferences. You can opt-out of receiving such emails at any time by clicking the unsubscribe link in the relevant email. Medtronic may use pixels and other technologies in emails to gather statistics around email opening and clicks, to help us improve our communications and to provide you with relevant content.

For more information, see the {link}

You can always change your preferences or update your personal details by visiting the {link}