St Jude’s Ablation Catheters and Generator have gained FDA (PMA) approval. The approval details can be found on FDA’s website here.
The Therapy Cool Path Duo™ Ablation Catheter and the Safire BLU Duo™ Ablation Catheter are steerable, deflectable, irrigated catheters used to treat atrial flutter by finding the source of the rhythm disturbance and ablating small areas of the heart tissue. The catheters take energy from an external source to a point in the right side of the heart. Cardiac catheter ablation can cure typical atrial flutter and restore a normal heart rhythm, and in other cases, can reduce the frequency of episodes that a patient experiences.
In a clinical study involving 188 patients, the abnormal rhythm was corrected in 181 patients (96%) for 7 days after treatment; and it remained corrected after 3 months in 174 patients (94.5%).
All the products listed in the PMA approval already carry CE mark approval.
Source: St Jude