Confirm Rx™ Insertable Cardiac Monitor | Abbott
CARDIOVASCULAR
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THIS DEVICE IS COMMERCIALLY AVAILABLE FOR USE IN SELECT INTERNATIONAL MARKETS.
THE WORLD'S FIRST SMARTPHONE-COMPATIBLE ICM

Providing patients with an easy-to-manage heart monitor just got smarter. The Confirm Rx™ ICM offers convenient, connected and continuous monitoring for insight into your patients’ conditions, including syncope, palpitations, and AF before or after ablation therapy and cryptogenic stroke—with fewer interruptions to their daily lives and reduced burden to your clinic.

THE CONFIRM Rx™ ICM WITH THE MYMERLIN™ MOBILE APP ENGAGES PATIENTS WITH EASY-TO-USE TOOLS AND ENABLES REMOTE MONITORING COMPLIANCE—AND IT IS ONLY FROM ABBOTT.

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.

EMPOWER AND ENGAGE PATIENTS
  • An all-in-one integrated transmitter and symptom recorder, functional via the myMerlin™ smartphone app, eliminates the need for a traditional radio-frequency (RF) based bedside transmitter, which can be intrusive and cumbersome for patients and limits their mobility.
  • 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.
ENHANCE PATIENT COMPLIANCE TO REMOTE MONITORING WITHOUT ADDITIONAL CLINIC BURDEN

The Confirm Rx™ ICM is the first and only system of its kind to enhance remote monitoring compliance without additional clinic burden:

  • Enables the patient to verify and view past transmissions, including recorded symptoms and symptom history, and reduce unnecessary patient inquiries to confirm successful data transfers.
  • Allows patients to send patient-triggered symptoms to the clinic without the need to wait for a nightly sync with a traditional transmitter.
  • Provides patients with gentle, automatic notifications when patients miss device checks or scheduled transmissions, saving follow-up burden for clinic staff.
EMPOWERING CARDIAC ARRHYTHMIA MANAGEMENT

The Confirm Rx™ ICM is part of our advanced ablation and integrated lab portfolios. When it comes to understanding and managing cardiac arrhythmias, we are your partner for life. Our vision is to transform the treatment of cardiac arrhythmias by designing cost‐saving technologies that span the patient care continuum and improve therapy outcomes. Read more about the portfolio and our approach to cardiac arrhythmia management.

REFERENCES

Bluetooth is a registered trademark of Bluetooth SIG, Inc.

THE ADVANTAGES OF CONFIRM Rx™ ICM

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 (MRI Ready) ease: The Confirm Rx™ ICM is conditionally safe for use in the MRI environment when used in accordance to the instructions in the user manual
EMPOWER AND ENGAGE PATIENTS

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.

ENHANCE PATIENT COMPLIANCE TO REMOTE MONITORING WITHOUT ADDITIONAL CLINIC BURDEN

By removing the need for a bedside transmitter and patient activator, Confirm Rx™ ICM simplifies cardiac monitoring for your patients. Traditional remote monitoring between RF devices and bedside transmitters is associated with poor patient compliance1 requiring clinic resources to ensure regular connection and transmissions. These transmitters tend to be bulky and difficult to travel with.

 

The myMerlin™ for Confirm Rx™ app 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
  • Allows patients to transmit patient-triggered symptoms immediately to the clinic, without the need to wait for nightly device sync to a traditional bedside transmitter

 

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

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

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

 

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 myMerlin™ 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.
EMPOWERING 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.

REFERENCES

Bluetooth and the Bluetooth figure mark are registered trademarks of Bluetooth SIG, Inc.

Limitations: Patients may use their own Apple or Android mobile 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 enabled and data coverage (cellular or Wi-Fi) 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.
1. Crossley, G. H., Boyle, A., Vitense, H., Chang, Y., & Mead, R. H. (2011). The CONNECT(Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: The value of wireless remote monitoring with automatic clinician alerts. Journal of the American College of Cardiology, 57(10),1181-1189. http://dx.doi.org/10.1016/j.jacc.2010.12.012

CONFIRM Rx™

Model DM3500
Insertable Cardiac Monitor

ORDERING INFORMATION

Reorder Number

 

Name

 

Model Number

 

Description
DM3500 Confirm Rx™ ICM DM3500 Insertable cardiac monitor

 

SEE FULL PRODUCT DETAILS and any references for this product.

Reorder Number

DM3500

Name

Confirm Rx™ ICM

Model Number

DM3500

Description

Insertable cardiac monitor

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