Cardima to begin Phase III US trial for AF (atrial fibrillation) catheter:
This article was originally published in Clinica
Cardima has received permission from the US FDA to begin the pivotal Phase III stage of its clinical trial to assess its Revelation Tx microcatheter-based ablation device for treating paroxysmal atrial fibrillation (AF). Data from Phase I and II of the US trial and from European trials and commercial use of the product indicate that about 80% of patients treated with the microcatheter have experienced either total elimination or a significant reduction in their AF, said Fremont, California-based Cardima. The product is already CE-marked for sale in Europe.