CardioMEMS, Inc., a member of Georgia Tech’s Advanced Technology Development Center, has announced 510(k) clearance and U.S. Launch of the EndoSure™ Wireless AAA Pressure Measurement System.
The company describes its wireless sensor monitoring technology:
The revolutionary EndoSure 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 the latest innovations in both microelectromechanical systems (MEMS) and wireless technologies, and comprises the EndoSure Sensor, a unique delivery catheter, the external interrogation device and proprietary software.
The EndoSure Wireless AAA Pressure Sensor is implanted during the endovascular aortic repair (EVAR) procedure and is compatible with all commercially available stent-grafts. Accurate pressure measurements within the aneurysm sac can be taken simply and efficiently. To take a measurement, the physician simply places the antenna on the patient’s abdomen and activates the Sensor using low power radio-frequency energy. A real-time, high-resolution pressure waveform is quickly displayed on a 15″ flat-panel touch screen monitor.
“We believe the EndoSure AAA Pressure Measurement System represents breakthrough technology that will provide a significant benefit both to the patient as well as to the physician performing endovascular aneurysm repair” said David Stern, President and CEO of CardioMEMS, Inc. “The results of our clinical trial demonstrate that we have developed a product that is safe and easy to use.”
Dr. Takao Ohki, Professor and Chief of Vascular Surgery at Montefiore Medical Center, Co-Principal investigator of the CardioMEMS, Inc. APEX clinical trial (Acute Pressure measurement to confirm aneurysm EXclusion) and the first physician in the world to implant the sensor in a patient commented “The implantation of the EndoSure is straightforward and safe. I believe that over time this important new technology may demonstrate its value by helping physicians confirm that aneurysms have been effectively treated with EVAR procedures and also identify problems that may arise.”