MedicalCV's cardiac ablation system:
This article was originally published in Clinica
Executive Summary
MedicalCV has received US FDA 510(k) market clearance to use its surgical ablation system, AtriLaze, on cardiac tissue in surgery. The clearance marks the firm's shift from the mechanical heart valve market, where it had reported "significant losses on modest revenues", into the faster-growing atrial fibrillation (AF) sector. The Minneapolis, Minnesota company expects to start marketing AtriLaze via a direct US sales force in January 2005.