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Cardima's cardiac ablation system:

This article was originally published in Clinica

Executive Summary

The US FDA has give Cardima 510(k) clearance to market its electrosurgical cutting and coagulation device for ablating cardiac tissue during heart surgery using radiofrequency (RF) energy. The system is expected to be used primarily by surgeons using standard hospital laparoscopic and thorascopic techniques. It comprises three components: RF generators; a surgical ablation probe with a linear array of multi-electrodes and adjacent thermocouples; and an energy management device called Intellitemp, which uses a temperature feedback feature to apply RF energy to single or multiple electrodes on the probe simultaneously. The Fremont, California firm said it was evaluating potential marketing and distribution strategies for the system.

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