Level 3 plus
I am a CE-certified medical device
I am safely connected
I have proven my social-economic evidence and get reimbursed by NIHDI
I am safely connected
I have proven my social-economic evidence and get reimbursed by NIHDI
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General description
Additional info
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Financing
General description (provided by company)
Main purpose
CareLink is a digital solution for remote monitoring of cardiac implanted patients. Patients are continuously monitored, and their clinical team receives scheduled and alert-based transmissions, as well as patient-initiated transmissions in case of symptoms. The app can be used to send heart device information to the patients’ care team, wherever they are and whenever needed. CareLink remote monitoring supports care teams in providing optimal follow-up by moving data instead of patients and enabling early notifications of important clinical or device-related events.
Target audience
The CareLink remote monitoring system is designed for the remote follow-up of patients implanted with a Medtronic pacemaker, defibrillator, CRT-D, CRT-P (cardiac resynchronization therapy defibrillator or pacemaker) or implantable cardiac monitor.
Patients owning a compatible smartphone and implanted with a compatible device can use the MyCareLink Heart app rather than a bedside monitor for continuous monitoring of their clinical and device parameters.
Patients owning a compatible smartphone and implanted with a compatible device can use the MyCareLink Heart app rather than a bedside monitor for continuous monitoring of their clinical and device parameters.
Approach
Device-related and physiologic patient data from the cardiac device (data typically reviewed by the clinicians during in-office visits) is transmitted to the CareLink Network so it can be reviewed by the clinical team through the CareLink website. The data are used by the clinical team to treat patients, optimize therapy, and clinically act in case of events.
For patients using the MyCareLink Heart app (alternative remote monitoring solution replacing the bedside monitor), the app acts only as pass-through to transmit the data. Patients can check information about transmission status, battery life but also record their vitals (weight, blood pressure), symptoms and physical activity as they wish.
For patients using the MyCareLink Heart app (alternative remote monitoring solution replacing the bedside monitor), the app acts only as pass-through to transmit the data. Patients can check information about transmission status, battery life but also record their vitals (weight, blood pressure), symptoms and physical activity as they wish.
Connectivity to sensors and platforms
The app is connected to the cardiac device of the patient and transmits to the CareLink Network.
The CareLink Network has built-in export capabilities to connect to hospital Electronic Health Records (EHR) or other platforms.
The CareLink Network has built-in export capabilities to connect to hospital Electronic Health Records (EHR) or other platforms.
Financing and pricing model
Financing and pricing model of the app still needs to be determined.
Pathology
Heart / Blood Vessels
Functions
Alerts & Notifications
Data Sharing
Diagnostics
Health Tracking
Remote Clinical Monitoring
Treatment Support
Users
Everyone
Additional info
Compliance to M3 criteria
This application has completed levels M1 and M2 of the pyramid, and the company declares to meet the criteria for mobile medical applications that NIHDI has set within the following specific care process:
Compliance to M1 criteria
CE certification
Certificate granted on 11/04/2022
Certificate valid till 10/04/2027
Class type of medical device (More info): 2A
ISO Standards:
FAMHP registration and notification
Company registration number at FAMHP: 00355
Product identification code at FAMHP: 604552
General Data Protection Regulation (More info)
The app is only available through prescription
Reference publication
- Tarakji K. et al. Impact of a Bluetooth-enabled cardiac device with a patient smartphone app on Clinic efficiency. JACC 2021; Volume 77, Issue 18.
- Tarakji KG et al. Performance of first pacemaker to use smart device app for remote monitoring.
- https://newsroom.clevelandclinic.org/2020/10/06/cleveland-clinic-unveils-top-10-medical-innovations-for-2021/
- Tarakji KG et al. Performance of first pacemaker to use smart device app for remote monitoring.
- https://newsroom.clevelandclinic.org/2020/10/06/cleveland-clinic-unveils-top-10-medical-innovations-for-2021/
User instructions
Patients use a bedside monitor or an MyCareLink HeartTM app to send data automatically and securely from their heart device to the CareLink platform. This allows clinicians to access patient data using the CareLink clinician website.
Patients using the app can transfer data automatically or manually to their care team from anywhere, at any time. This contributes to improved adherence to follow up and delivering quality of care in line with guidelines. Additionally, it provides patients peace of mind with access to select heart device data, such as connectivity and transmission status, battery life and activity level. Ultimately, the app includes education articles about living with their device and enables patients to track their vitals and symptoms. The app user interface is easy to use and built based on patient feedback.
Detailed user instructions provided to patients and clinicians can be shared upon request.
Patients using the app can transfer data automatically or manually to their care team from anywhere, at any time. This contributes to improved adherence to follow up and delivering quality of care in line with guidelines. Additionally, it provides patients peace of mind with access to select heart device data, such as connectivity and transmission status, battery life and activity level. Ultimately, the app includes education articles about living with their device and enables patients to track their vitals and symptoms. The app user interface is easy to use and built based on patient feedback.
Detailed user instructions provided to patients and clinicians can be shared upon request.
Components of the application
Native appWeb applicationMedical device
Complaints handling
Via e-mail: rick.paauw@medtronic.comVia telephone: +31 6 20 04 06 14
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