AtriCure's improved tissue ablator:
This article was originally published in Clinica
Executive Summary
The US FDA has given AtriCure 510(k) marketing clearance to use its Isolator Synergy bipolar ablation system on soft tissue. The device is a next generation version of the firm's FDA-cleared Isolator bipolar ablation system; neither product has yet been cleared for cardiac use or for treating atrial fibrillation. It incorporates two pulsing pairs of electrodes in the jaws of the clamp to create a uniform, full-thickness ablation lesion shaped like a column, which the West Chester, Ohio firm believes will result in more durable ablation lines in thicker and more diseased tissues. The company anticipates launching a minimally-invasive version of the device during the third quarter of 2007.