Medtronic's non-invasive cardiac 3D mapping system is approved by the FDA: complete 3D mapping of the heart

The CardioInsight ECVUE system is the first commercially available non-invasive cardiac 3D mapping system from Medtronic, which received FDA 510(k) approval in early February.

Usually doctors need to figure out what causes arrhythmia and require an invasive procedure that involves inserting a catheter into an artery or vein to get a "map" of the heart and then looking for the cause of the arrhythmia. The ECVUE system developed by CardioInsight non-invasively generates cardiac electrical activity images through a wearable vest that combines electrical signals from the body surface and 3D anatomical data. The system further reconstructs and displays 3D composition and other helpful cardiac electrical signal data. .

Since the ECVUE system is non-invasive and can be operated outside of the EP catheter, it simplifies the planning and mentoring steps for ablation and cardiac resynchronization therapy. The ECVUE system's real-time intraoperative system provides a variety of key intracardiac electrogram information that can be used to understand, plan, and monitor the treatment process during surgery.

美敦力无创式心脏3D标测系统获FDA批准:可完成心脏3D图谱绘制

The ECVUE system consists of four main components: a vest, software, amplifiers and displays. The vest has 252 electrode sensors that capture the ECG signal, provide an electroanatomical 3D map of the upper and lower parts of the heart, pair it with the collected ECG signals, and connect to the CardioInsight workstation in conjunction with the CT scan data.

The ECVUE system and its unique non-invasive ECG mapping technology are now clinically used for 1,600 patients and published in more than 100 publications.

美敦力无创式心脏3D标测系统获FDA批准:可完成心脏3D图谱绘制

“This technology has been in development for decades and has made new advances in non-invasive testing for arrhythmia research and treatment,” said Colleen Fowler, vice president and general manager of Medtronic's AF solutions.

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