CardioMEMS announces FDA clearance, product launch

Nov. 14, 2005 — CardioMEMS Inc., an Atlanta company focused on the application of MEMS technology to create innovative medical devices, announced U.S. Food and Drug Administration (FDA) clearance and the U.S. market launch of its EndoSure Wireless AAA Pressure Measurement System.

CardioMEMS says FDA clearance was based upon completion of a multi-center, international clinical study in which more than 100 patients in Brazil, Argentina, Canada and 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.

The company says the sensor is the first wireless, un-powered, permanently implantable pressure sensor for human use to be commercially available in the United States. The system is based on innovations in both MEMS and wireless technologies. It is comprised of the EndoSure sensor, a unique delivery catheter, the external interrogation device and proprietary software. CardioMEMS says the sensor, which is implanted during the endovascular aortic repair procedure, is compatible with all commercially available stent-grafts.

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