CardioMEMs Receives FDA Clearance on Pressure Measurement System for TTA Repair

 

April 1, 2007

April 2, 2007 — CardioMEMS Inc. has announced the FDA has cleared the EndoSure AAA Wireless Pressure Measurement System for measuring intrasac pressure during thoracic aortic aneurysm (TAA) repair.

The EndoSure Wireless AAA Pressure Measurement System is comprised of an implanted sensor and an external electronics module. The EndoSure sensor is inserted during the minimally invasive cardiovascular repair of an abdominal aortic aneurysm or thoracic aortic aneurysm via a catheter into a patient's aneurysm sac and measures and communicates pressure information to an external electronics module from inside the sac. The information is processed in real time and displayed as a pressure waveform. The sensors are designed to measure vital medical parameters such as mean pressure, systolic pressure, diastolic pressure, heart rate and cardiac output.

The EndoSure sensor is designed and manufactured using microelectromechanical systems, or MEMS, technology, which enables the fabrication of millimeter-scale devices with internal features in the nanometer to micrometer range. MEMS technology allows the creation of sensors with measurement stability and energy efficiency.