Medtronic's ECVUE Vest Receives FDA 510(k) Clearance for Non-Invasive 3D Cardiac Mapping

CardioInsight’s ECVUE system, the first commercial non-invasive 3D cardiac mapping system launched by Medtronic, received FDA 510(k) clearance in early February.

Typically, physicians must perform an invasive procedure involving the insertion of a catheter into an artery or vein to obtain an electrical “map” of the heart and identify the underlying cause of arrhythmia. In contrast, CardioInsight’s ECVUE system noninvasively generates images of cardiac electrical activity by combining body-surface electrical signals with 3D anatomical data captured via a wearable vest. The system further reconstructs and displays 3D mappings along with other clinically relevant cardiac electrical signal data.

As the ECVUE system is non-invasive and can be operated outside the electrophysiology (EP) laboratory, it simplifies the planning and guidance steps for ablation and cardiac resynchronization therapy. The ECVUE system’s real-time intraoperative platform provides various critical intracardiac electrogram data, which can be used during procedures to understand, plan, and monitor the therapeutic process.

The ECVUE system comprises four main components: a vest, software, an amplifier, and a display. The vest is equipped with 252 electrode sensors on its surface to capture electrocardiographic signals, providing 3D electroanatomic maps of the superior and inferior aspects of the heart. These maps are paired with the collected body-surface ECG signals and integrated with CT scan data via the CardioInsight workstation.

The ECVUE system and its proprietary non-invasive electrocardiographic mapping technology have been clinically utilized in 1,600 patients, with related studies published in over 100 publications.

“This technology has evolved over decades and has achieved new advances in the research and treatment of non-invasive cardiac arrhythmia,” said Colleen Fowler, Vice President and General Manager of AF Solutions at Medtronic.

Dr. Vivek Reddy, Director of Arrhythmia Services at Mount Sinai Hospital and a consultant for Medtronic, was the first to use the device commercially.

“This system enables the acquisition of cardiac maps outside the EP lab, saving time and enhancing patient experience,” said Reddy. “By providing this non-invasive approach, it effectively streamlines clinicians’ procedural planning workflow, allowing for precise localization results to be readily obtained at the patient’s bedside.”

Medtronic acquired CardioInsight, a Cleveland-based company, in 2015. Headquartered in Cleveland, Ohio, the privately held medical device company successfully developed new systems to improve mapping technologies for cardiac arrhythmias. Medtronic completed the acquisition on a debt-free basis for approximately $93 million.