Angiology
ProRhythm initiates U.S. pivotal trial for HIFU ablation system
Published in Medical Letter on the CDC and FDA, February 18th, 2007
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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