CARDIOVASCULAR
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CAPTURING THE RHYTHM OF LIFE

The Confirm Rx™ insertable cardiac monitor (ICM) with SharpSense™ technology delivers the necessary information you need to clearly and confidently diagnose difficult to detect arrhythmias with fewer interruptions to patients’ daily lives.

THE CONFIRM Rx™ ICM WITH SHARPSENSE™ TECHNOLOGY AND THE myMERLIN™ MOBILE APP ENGAGES PATIENTS WITH EASY-TO-USE TOOLS AND ENABLES REMOTE MONITORING COMPLIANCE

The Confirm Rx™ ICM with SharpSense™ technology combines a quick and minimally invasive procedure with Bluetooth® wireless technology, allowing patients to connect using their own mobile devices.

WATCH A BRIEF OVERVIEW OF THE CONFIRM Rx™ ICM.
Screencap for the Confirm Rx ICM with the MyMerlin Overview Video
DELIVER CONVENIENTLY
REMOTE MONITORING HAS NEVER BEEN SO ENGAGING

Remote monitoring via smartphone connectivity with an easy-to-use app encourages patient compliance with less disruption to their daily lives.

  • 97% of registered myMerlin™ for Confirm Rx™ ICM mobile app users transmitted at least once.1
  • 1.6 days is the average time between transmissions.1
  • Data is proactively transmitted by the myMerlin™ for Confirm Rx™ ICM mobile app per a schedule set by your clinic.
  • The app automatically informs patients of successful device checks and clinic-scheduled transmissions or notifies them when one has been missed.
  • Patients can send patient-triggered symptoms to the clinic without the need to wait for a nightly sync with a traditional transmitter.
DETECT ACCURATELY
CONFIRM Rx™ ICM WITH SHARPSENSE™ TECHNOLOGY SIGNIFICANTLY IMPROVES BRADYCARDIA, PAUSE AND ATRIAL FIBRILLATION (AF) DETECTION, ENSURING YOU SEE WHAT YOU NEED TO KNOW ABOUT YOUR PATIENTS

SharpSense™ technology is designed with more discriminators, improving specificity while maintaining a high relative sensitivity, to give you actionable information you can use to confidently diagnose Bradycardia, Pause and AF.2 In addition, there are print scatterplots to better identify trends for your patients.

AN INCREASE IN DISCRIMINATORS HAS LED TO A 97% REDUCTION IN FALSE DETECTION OF EVENTS3*

 

RHYTHM RELATIVE
SENSITIVITY
BRADYCARDIA 98.6%2
PAUSE 98.1%2
AF 97.2%2

JEAN'S STORY: AN ANIMATED PATIENT EXPERIENCE

Jean is one of the many patients who now use Bluetooth® technology and Confirm Rx™ ICM to monitor his condition. This short animation tells his patient story.

Screencap of Jean's ConfirmRx ICM patient story.
BUILDING COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

The Confirm Rx™ ICM with SharpSense™ technology 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
Confirm Rx™ ICM Physician Brochure

REFERENCES

Bluetooth is a registered trademark of Bluetooth SIG, Inc.
* Determined by evaluation of real-world episodes in previously identified devices, using SharpSense technology.
1. Priorkowski C, et al. Early real-world adoption of mobile remote monitoring using the Confirm Rx Insertable Cardiac Monitor. Poster presented at APHRS. 2018.
2. Design Validation Report and Trace Matrix, Insertable Cardiac Monitor (ICM) System DOC 60076435 Rev. E March 2019.
3. Evaluation of Clinic Impact of Confirm Rx 1.2 Algorithm Enhancements. Abbott document 60098828. April 2019.

THE ADVANTAGES OF CONFIRM Rx™ ICM WITH SHARPSENSE™ TECHNOLOGY

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

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

  • SharpSense technology improves the detection of Bradycardia, Pause and Atrial Fibrillation (AF) with high relative sensitivity and significant reduction of false positive episodes1
  • EGM scatterplot reports available as part of episode reports to help streamline data interpretation
  • 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
ENHANCE PATIENT COMPLIANCE TO REMOTE MONITORING

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

  • 97% of registered myMerlin™ for Confirm Rx™ mobile app users transmitted at least once.2
  • 1.6 days is the average time between transmissions.2
Smarter connectivity from Confirm Rx ICM to Patient Smartphone to Clinician Portal

 

The myMerlin™ mobile app for 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.

Download on the App Store

Get it on Google Play

EMPOWER AND ENGAGE PATIENTS

The downloadable myMerlin™ for Confirm Rx™ ICM 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® 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
  • The Confirm Rx™ ICM with SharpSense™ technology 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 with SharpSense™ technology 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 device denies access.
  • The Confirm Rx™ ICM with SharpSense™ technology uses an authorization protocol, which limits a paired mobile app's access based on clinician settings. 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 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 with SharpSense™ technology 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.
BUILDING COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

The Confirm Rx™ ICM with SharpSense™ technology 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
Confirm Rx™ ICM Physician Brochure

REFERENCES

® Bluetooth and the Bluetooth figure mark are registered trademarks of Bluetooth SIG, Inc.
Apple, the Apple logo, iPhone, and iPad are trademarks of Apple Inc., registered in the U.S. and other countries and regions. App Store is a service mark of Apple Inc.
1. Design Validation Report and Trace Matrix, Insertable Cardiac Monitor (ICM) System DOC 60076435 Rev E March 2019.
2. Priorkowski C, et al. Early real-world adoption of mobile remote monitoring using the Confirm Rx Insertable Cardiac Monitor. Poster presented at APHRS. 2018.

Confirm Rx™ ICM with SharpSense™ Technology

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.

 

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. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm Rx™ ICM has not been specifically tested for pediatric use.

Contraindications: There are no known contraindications for the insertion of the Confirm Rx™ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted 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.

Additional information: Clinicians must log onto Merlin.net™ Patient Care Network to view transmissions from patients’ Confirm Rx™ ICM. On Merlin.net™ PCN they can configure transmission schedules and enable or disable features on a patient’s myMerlin™ for Confirm Rx™ ICM mobile app. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions.

Limitations: Patients may use their own Apple‡ or Android‡ mobile device to transmit information from their Confirm Rx™ ICM using the myMerlin™ for Confirm Rx™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology enabled and data coverage (cellular or WiFi‡) available. The myMerlin™ for Confirm Rx™ mobile app provides periodic patient monitoring based on clinician configured settings. Data is resent if the transmission was 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.

An Abbott mobile transmitter is available for patients without their own compatible mobile device.

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