SmartView Connect App - Implantable cardiac device management application software

Intended purpose

The SmartView Connect™ App is indicated for the remote follow up of patients who are implanted with a MicroPort CRM Bluetooth®-enabled cardiac device, according to applicable Medical Guidelines (2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2019;140:e382-e482.) and (2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death). It is worth noting that in-clinic follow-up of patients implanted with a cardiac device is still indicated and is in no way replaced, under any circumstances, by this remote monitoring technology.

Functional description

The SmartView Connect application is part of the SmartView Remote Monitoring System (RMS), which is composed of the software itself installed on a mobile device and a back-office data management system controlled by MicroPort CRM. The purpose of the system is to remotely monitor MicroPort CRM implanted Bluetooth®-enabled cardiac device in patients’ homes.