US clears 3-D mapping system for right atrium use:
This article was originally published in Clinica
Executive Summary
The US FDA has cleared Endocardial Solution's EnSite 3000 mapping system for diagnosing complex arrhythmias in the right atrium of the heart. By providing three-dimensional mapping of the whole chamber, the system makes possible ablation therapy for patients with atrial arrhythmias, said the St Paul, Minnesota-based company. The FDA is currently reviewing a premarket approval application to use the system for left ventricular investigations. The system is already available in Europe for both right atrial and left ventricular use - under a distribution agreement with Medtronic.