Popular Science describes it as a "best innovation of the year."
TIME calls it a "guardian for heart health."
Our Confirm RxTM Insertable Cardiac Monitor — the world's first and only smartphone-compatible ICM — is receiving major kudos for the innovative way it helps patients and physicians detect arrhythmias (irregular heartbeats) that can lead to heart failure.
For their "Best of What's New Awards," PopSci's editors search each year to find the top 100 tech innovations — exemplary breakthrough products and technologies that demonstrate significant advancement in their categories. Included in the "Best of" list, Best of What's New Awards, editors recognized Confirm Rx ICM as a life-changing technology for 2018.
And like their counterparts at Popular Science, TIME reviews thousands of new products and innovations for its list of the year's best inventions based on key factors, including originality, creativity, influence, ambition and effectiveness. For its transformative impact on the way physicians and patients keep track of irregular heart rhythms, Confirm Rx ICM earned an honorable mention in TIME's Best Inventions of 2018.
The Confirm Rx ICM leverages real-time data on potential arrhythmias and syncs with smartphones to keep physicians informed and patients engaged. It is designed to help physicians remotely identify even the most difficult to detect cardiac arrhythmias (irregular heartbeats), including atrial fibrillation.
"These honors are a huge testament to the hard work put in by our team to ensure doctors have real-time information, from anywhere in the world, on how their patient’s heart is performing," said Mike Pederson, Senior Vice President of Cardiac Arrhythmias and Heart Failure at Abbott. "We are improving the lives of people through innovation and giving them peace of mind while living with a complex heart condition."
The Confirm Rx ICM system provides patients a new way to monitor for abnormal heart rhythms while staying connected to their physician remotely and engaged in their health care. For physicians, the device allows for effective management of patients while enhancing patient compliance through smartphone connectivity.
IMPORTANT SAFETY INFORMATION
RX ONLY
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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