Angiology

ProRhythm initiates U.S. pivotal trial for HIFU ablation system

Published in Health Business Week, February 16th, 2007

ProRhythm, Inc. announced the treatment of the first patient with the company's proprietary HIFU (high intensity focused ultrasound) Ablation System in the "focusAF" clinical study for the treatment of atrial fibrillation (AF).

This is a critical step in the U.S. Food & Drug Administration approval process and comes after the successful conclusion of the feasibility phase of the trial.

The "focusAF" trial, the pivotal trial in the FDA approval process, will involve over 20 U.S. cardiac electrophysiology centers that specialize in the treatment of atrial fibrillation.

"The initiation of the pivotal study is a critical step along...

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Source: Health Business Week (2007-02-16)

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