FDA Clears Flexible EP Ablation Catheter


January 23, 2014
Irvine Biomedical Therapy Cool Flex Ablation Catheter St. Jude Medical

Irvine Biomedical Inc.’s Therapy Cool Flex Ablation Catheter is a steerable, deflectable, irrigated catheter used to treat atrial flutter by finding the rhythm disturbance source and ablating small areas of the heart tissue. The catheter takes energy from an external source, the IBI1500T9-CP V1.7 Cardiac Ablation Generator, to a point in the right side of the heart.  The pattern of the ablation catheter laser-cut electrode tip allows flexibility and provides a more uniform distribution of saline fluid to the ablation site. Cardiac catheter ablation can cure typical atrial flutter and restore a normal heart rhythm. In other cases, it can reduce the frequency of episodes a patient experiences. The device is contra-indicated in patients who have an active systemic infection, a blood clot attached to the inside of the heart or an incision in the atrium or ventricle from within the last four weeks. The FDA cleared Irvine Biomedical Inc.’s Therapy Cool Flex Ablation Catheter and IBI 1500T9-CP v.1.7 Cardiac Ablation Generator in January 2014.  For more information: www.accessdata.fda.gov