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news.AtriCure has announced that its Coolrail linear ablation pen received 510(k) clearance from the FDA for the ablation of cardiac tissue.
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The Coolrail linear ablation pen is designed to facilitate the creation of an expanded cardiac ablation lesion set during a minimally invasive off-pump procedure. Additionally, the first patient was successfully treated using the AtriCure Coolrail Linear Ablation Pen.
David Drachman, president and CEO of AtriCure, said: “During 2008 we plan on initiating enrollment in our FDA regulated clinical trial, Restore SR-IIB. This prospective, non-randomized, feasibility trial will enroll 25 patients at five leading US medical centers. The results of Restore SR-IIB will be used to design and support US pivotal trials of our minimally invasive sole-therapy ablation system for the treatment of atrial fibrillation.”