FDA Announces FDA Clearance of the EndoSure Wireless AAA 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.
About CardioMEMS, Inc.
CardioMEMS, Inc. is a medical device company that has developed and is commercializing a proprietary wireless sensing and communication technology for the human body. CardioMEMS' technology platform is designed to improve the management of severe chronic cardiovascular diseases such as heart failure, aneurysms and hypertension.
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the Company's products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.
CardioMEMS, CardioMEMS logos and EndoSure are trademarks of CardioMEMS, Inc.
CONTACT: CardioMEMS, Inc. Bud Ingalls, CFO 404-920-6735
Keywords: HEALTH, MEDICAL, ELECTRONICS