CARDIOVASCULAR
hamburger
product photo
THE WORLD'S FIRST SMARTPHONE-COMPATIBLE ICM

The Confirm Rx™ ICM offers convenient, connected and continuous monitoring for insight into your patients' conditions and symptoms, including syncope, palpitations, and AF before or after ablation therapy and cryptogenic stroke - with fewer interruptions to their daily lives.

The Confirm Rx™ ICM with the MyMerlin™ mobile app engages patients with easy-to-use tools and enables remote monitoring compliance.
 
CONVENIENT
EFFECTIVELY MANAGE PATIENTS WITH A QUICK AND MINIMALLY INVASIVE PROCEDURE AND STREAMLINED REMOTE FOLLOW-UP.

The Confirm Rx™ ICM is the world's first insertable cardiac monitor that combines a quick and minimally invasive procedure with Bluetooth® low energy wireless technology, allowing patients to connect using their own mobile devices.

CONNECTED
ENHANCE PATIENT COMPLIANCE WITH SMARTPHONE CONNECTIVITY

The myMerlin™ mobile app allows the Confirm Rx™ ICM to connect directly to a patient’s existing smartphone. By allowing patients to initiate recording and transmit symptoms with a smartphone-based app, Confirm Rx™ ICM brings continuous remote monitoring to patients without the need for a separate home-based transmitter or separate patient activator.

The myMerlin™ mobile app, designed with patient input, allows them to:

 

  • View their transmissions and symptom history without having to contact the clinic to confirm successful data transfers.
  • Send patient-triggered symptoms to the clinic without the need to wait for a nightly sync with a traditional transmitter.
  • Receive automatic notifications when they miss device checks or scheduled transmissions, reducing follow-up burden for clinic staff.
CONTINUOUS
EMPOWER AND ENGAGE PATIENTS
  • The first and only monitoring system to eliminate the need for a bedside transmitter and separate activator.
  • An all-in-one integrated transmitter and symptom recorder, functional via the myMerlin™ mobile app.
  • A direct connection to the myMerlin™ mobile app via Bluetooth® wireless technology. Data is proactively transmitted by the app per a schedule set by your clinic, thereby minimizing interruptions to your patients’ daily lives.
  • The app automatically connects with the device via Bluetooth® low energy wireless technology, and informs patients of successful device checks and clinic-scheduled transmissions, without interrupting their daily lives.
BUILDING COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

The Confirm Rx™ ICM is part of our arrhythmia management portfolio. Our vision is to transform the treatment of cardiac arrhythmias by designing cost-saving technologies that improve therapy outcomes. Read more about the portfolio and our approach to cardiac arrhythmia management.

RESOURCES AND DOCUMENTATION

Product Manuals (Instructions for Use)
Reimbursement Information
MRI Ready and Scan Parameters

REFERENCES

Bluetooth is a registered trademark of Bluetooth SIG, Inc.

 

THE ADVANTAGES OF CONFIRM Rx™ ICM

EFFECTIVELY MANAGE PATIENT WITH A QUICK AND MINIMALLY INVASIVE PROCEDURE AND STREAMLINED REMOTE FOLLOW-UP.

With the Confirm Rx™ ICM, you and your patients can benefit from the device's features:

  • Small size (~1.4 cc) with slim profile
  • Simple insertion procedure requiring minimal time and resources
  • Programmable data storage options to ensure capture of significant events and reduce the risk that unexpected events are missed
  • MR Conditional: The Confirm Rx™ ICM is conditionally safe for use in the MRI environment when used in accordance to the instructions in the user manual
ENHANCE PATIENT COMPLIANCE WITH SMARTPHONE CONNECTIVITY

By removing the need for a bedside transmitter and patient activator, Confirm Rx™ ICM simplifies cardiac monitoring for your patients.

 

 

The Confirm Rx™ ICM also:

  • Automatically connects with the device via Bluetooth® low energy wireless technology, and informs patients of successful device checks and clinic-scheduled transmissions, without interrupting their daily lives
  • Alerts patients to connection problems via simple app-based notifications, helping them stay compliant to remote monitoring

 

Download the myMerlin™ for the Confirm Rx™ app today. The app is free and contains a full demo.

apple_iconVisit the Apple‡ App Store to download the myMerlin™ for Confirm Rx™ app

google_play_iconVisit Google Play‡ Store to download the myMerlin™ for Confirm Rx™ app.

 

EMPOWER AND ENGAGE PATIENTS WITH THE INTUITIVE MYMERLIN™ MOBILE APP

The downloadable myMerlin™ mobile app serves as an integrated transmitter and symptom recorder, as well as a repository of resources for the patient. Help your patients discover greater freedom, increased mobility and better engagement in their own care.

Direct Bluetooth® low energy wireless technology connection to the device and the intuitive design of the myMerlin™ mobile app helps patients stay connected, making it easier for them to transmit data according to the clinic-prescribed schedule.

The myMerlin™ mobile app for Confirm Rx™ ICM:

  • Offers patients app-based recording of symptomatic events and automatic upload of clinic-scheduled transmissions-all via their own smartphones-with minimal disruptions to their daily lives
  • Allows patients to annotate symptomatic events with specific keywords, such as "fainted" or "fluttering," providing greater clinician insights for confident diagnosis

Patients without a smartphone can receive an Abbott-provided smartphone.

SECURE AND PROTECTED REMOTE MONITORING
  • Encrypted wireless communication uses AES-128 bit encryption and is designed to limit communications to only a single authenticated and paired myMerlinTM mobile app at any given time.
  • The Confirm Rx™ ICM uses a proprietary pairing protocol as an added control measure in addition to the pairing procedure specified in Bluetooth® low energy protocols. Pairing requests are authenticated using cloud-based public key cryptography authentication.
  • The Confirm Rx™ ICM creates a unique 128-bit key for the paired mobile app and verifies it at the onset of every communication. If the unique key is not verified, the Confirm Rx™ ICM denies access.
  • The Confirm Rx™ ICM uses an authorization protocol, which limits a paired mobile app's access based on clinician settings.
  • The myMerlin™ mobile app encrypts wireless communication to Merlin.net™ PCN through a secure TLS connection using SHA256 cryptographic protection.
  • Merlin.net™ PCN is housed in a secured data center and is ISO 27001:2013 certified. Access to patient data in Merlin.net™ PCN is restricted to authorized users as set by the clinic administrator. Confirm Rx™ ICM data is encrypted using AES-128 bit encryption.
  • Merlin.net™ PCN is successfully certified through the EU-US Privacy Shield program to transfer patient information from the EU to the US.
REFERENCES

‡ Trademarks, including logos, and service marks marked with a ‡ indicates that the trademark is a registered or unregistered third party trademark and the property of its respective owner. See Terms and Conditions.
® Bluetooth and the Bluetooth figure mark are registered trademarks of Bluetooth SIG, Inc.

CONFIRM Rx™

Model DM3500
Insertable Cardiac Monitor

ORDERING INFORMATION

 

Reorder Number

DM3500

Name

Confirm Rx™ ICM

Model Number

DM3500

Description

Insertable cardiac monitor

SEE FULL PRODUCT DETAILS and any references for this product.

 

CUSTOMER
SERVICE

Our customer service experts can help with your
product orders or questions.

OUR PRODUCTS

See our featured innovations and technologies, full product catalog and approach to disease state management.

INDICATIONS, SAFETY & WARNINGS

INDICATIONS, SAFETY & WARNINGS

Confirm Rx™

Model DM3500
Insertable Cardiac Monitor

Indications: The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. Confirm Rx ICM Model DM3500 is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

Contraindications: There are no known contraindications for the implantation of the Confirm Rx ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.

Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Limitations: Patients may use their own Apple or Android mobile digital device to transmit information from their Confirm Rx ICM using the myMerlin™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology connection enabled and data coverage (cellular or WiFi) available. The myMerlin™ app provides periodic patient monitoring based on clinician configured settings. Transmission data is resent if not sent successfully. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, ICM memory capacity, clinic environment, schedule/configuration changes or data processing.

SJM-CV WEB-0718-0021(1)

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott.


The website that you have requested also may not be optimized for your screen size.

Do you wish to continue and exit this website?

true
accessibility
© 2016 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

accessibility

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott.


The website that you have requested also may not be optimized for your screen size.

Do you wish to continue and exit this website?