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news.St Jude Medical has received European CE Mark approval and FDA clearance for the Epicor LP cardiac ablation system, a second generation technology that uses high intensity focused ultrasound to surgically ablate cardiac tissue to disrupt abnormal electrical impulses in the heart.
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According to the company, the Epicor LP system has a lower profile as well as other features designed to facilitate easier device introduction and placement around and on patients’s hearts. In addition, the Epicor LP system is said to be equally suited for use in both closed-chest procedures performed through a single incision, and in open-chest procedures.
The first generation Epicor system gained regulatory approval for the treatment of atrial fibrillation (AF) in Europe in 2006. In the US, the first generation Epicor system and the Epicor LP system received clearance from the FDA for the surgical ablation of cardiac tissue but have not been indicated by the FDA specifically for the treatment of AF.