Business Update

Medical device maker to market AtriLaze Surgical Ablation System

Published in Medical Letter on the CDC and FDA, January 16th, 2005

MedicalCV, Inc. (BULLETIN BOARD: MDCV), announced that it received 510(k) clearance from the U.S. Food and Drug Administration to market its AtriLaze Surgical Ablation System for use on cardiac tissue in surgery.

The company expects to commence marketing its AtriLaze System via a direct U.S. sales force.

"This 510(k) clearance is just one more milestone achieved by the new management at MedicalCV," said Marc P. Flores, president and chief executive officer. "With a repopulation of management, 'right sizing' of the company, exiting the valve business, obtaining a 510(k) clearance on our AtriLaze System, and a directed focus into the atrial...

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Source: Medical Letter on the CDC and FDA (2005-01-16)

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