CARDIOMEMS, INC ANNOUNCES 510(K) CLEARANCE AND U.S. LAUNCH OF THE ENDOSURE WIRELESS AAA PRESSURE MANAGEMENT SYSTEM

CardioMEMS recently announced U.S. Food and Drug Administration (FDA) clearance and U.S. market launch of the EndoSure Wireless AAA Pressure Measurement System. FDA clearance was based upon completion of a multi-center, international clinical study in which over 100 patients in Brazil, Argentina, Canada and at nine hospitals in the United States successfully received an EndoSure sensor at the same time they had a stent-graft inserted to repair their aortic aneurysm. Implantation of the EndoSure Wireless AAA Pressure Sensor did not lead to any adverse events in the clinical trial.
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