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Confirm Rx

Insertable Cardiac Monitor with SharpSense Technology

ABOUT CONFIRM Rx ICM

The Confirm Rx™ insertable cardiac monitor with SharpSense™ technology, along with the myMerlin™ mobile app, is designed to help you clearly and confidently diagnose difficult to detect arrhythmias.

  • Designed with more discriminators, SharpSense technology improves specificity while maintaining a high relative sensitivity to better diagnose and identify trends for your patients.1
  • The Confirm Rx ICM connects directly to the myMerlin mobile app—offering your patients easy-to-use remote monitoring tools for increased engagement and less disruption to their daily lives.

CONFIRM Rx ICM PRODUCT INFORMATION

   How It Works

Silhouette with Confirm Rx ICM and silhouette at clinician portal are connected by bluetooth, wifi, and smartphone symbols.
How the Confirm Rx ICM with SharpSense Technology works
Education & Training

Education & Training

Get the latest information on updates to Merlin.net PCN for ICM

Get the latest information on updates to Merlin.net PCN for ICM

Reimbursement & Coding Highlights

Our full reimbursement resource documents provide information about coverage, coding and payment, denied claims and supporting documentation for the Confirm Rx ICM.

For the full resource list, visit Reimbursement & Coding for the Confirm Rx ICM.

Manuals & Resources

Manuals & Resources

Cardiovascular Products

Cardiovascular Products

Customer Service

Customer Service

Resources

  1. Design Validation Report and Trace Matrix, Insertable Cardiac Monitor (ICM) System DOC 60076435 Rev. E March 2019.
  2. Nölker, Georg & Mayer, Julia & Boldt, Leif-Hendrik & Seidl, Karlheinz & Van Driel, Vincent & Massa, Thomas & Kollum, Marc & Brachmann, Johannes & Deneke, Thomas & Hindricks, Gerhard & Jung, Werner & J. Brunner, Kyle & Kraus, Stacia & Hummer, Alexander & Lewalter, Thorsten. (2016). Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. Journal of Cardiovascular Electrophysiology. https://doi.org/10.1111/jce.13089

 

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.

Please see Indications, Safety & Warnings.

MAT-2011206 v1.0

POLICIES & ADVISORIES
HEALTHCARE PROFESSIONALS
PATIENTS & CAREGIVERS
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CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

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