Cardima submits cardiac ablation system 510(k):
This article was originally published in Clinica
Cardima has submitted to the US FDA a 510(k) marketing application for a surgical ablation system for use in minimally invasive cardiac surgery. The system uses commercially available electro-surgical radiofrequency (RF) generators, a Cardima surgical probe employing multi-electrode linear array microcatheter technology, and a power-channelling device, INTELLITEMP, which allows the surgeon to apply RF energy to any or all of the individual electrodes on the probe. The Fremont, California firm said that the product was part of its "atrial fibrillation strategy" to develop less invasive tools for treating irregular heart rhythms.