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AHA In Brief: Cardima RF catheter

This article was originally published in The Gray Sheet

Executive Summary

Cardima RF catheter: Company launches Revelation radiofrequency catheter for mapping cardiac arrhythmias at the annual AHA conference in Orlando after gaining 510(k) clearance. The device's small outer diameter (3.3 F) and multi-electrode design allow a more rapid and complete evaluation of the atria, reducing exposure to fluoroscopy, Cardima claims. Five direct sales reps will market the Revelation, which lists for $1,095. By the end of the year the firm expects to submit an Investigational Device Exemption to study use as a treatment for atrial fibrillation and ventricular tachycardia ablation. Cardima is seeking CE Mark approval for use of the Revelation for AF ablation. The catheter has been available in Europe for diagnostic use under the brand name Pathfinder since March 1996...
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