EndoSure® Wireless AAA Pressure Measurement System

The EndoSure® Wireless AAA Pressure Measurement System is cleared by the FDA for the measuring of intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and during endovascular thoracic aortic aneurysm repair (TAA). It serves as an adjunctive tool in the detection of intraoperative leaks of the stent graft during AAA repair.

The EndoSure sensor is inserted during the minimally invasive repair via a catheter into a patient’s aneurysm sac and communicates pressure information to an external electronics module from inside the sac.

Technology Overview

The EndoSure Wireless Pressure Measurement System is composed of two components: a miniaturized, wireless implantable sensor and an external electronics module. The external electronics module wirelessly communicates with our sensors to deliver vital patient data. Our wireless sensors are powered by RF energy delivered by an external electronics module and transmit real-time data without batteries.

CardioMEMS EndoSure Wireless Pressure Sensor 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. The EndoSure sensor is approximately the size of a paperclip. It is a hermetically sealed circuit, encapsulated in fused silica and silicone, and is surrounded by a PTFE-coated nickel-titanium wire. Inside the fused silica is a micron scale cavity. Changes to the membrane of this cavity result in changes to the sensor's resonant frequency. These changes correlate to pressure changes. The sensor contains no batteries or internal power source, but is instead powered by RF-energy provided by a proprietary electronic antenna.

The EndoSure sensor comes pre-loaded in a one-piece 14 French delivery system that enables the physician to insert the sensor during the same procedure as the stent graft. Radiopaque markers assist the physician in delivery of the sensor by clearly defining the sensor location within the aneurysm sac between the stent graft and aortic wall. The EndoSure sensor is intended to be a permanent implant in the aneurysm sac. Click here to view procedure animation.

EndoSure Sensor implanted in aneurysm sac repaired using endovascular repair procedure.

The external electronics module consists of three parts: the internal signal processing electronics, or main unit, the antenna used to wirelessly communicate with the sensor, and the graphical user interface that displays the patient information. During a reading, the antenna is placed near the implant site and communicates with the sensor by way of a RF signal that is generated and processed by the main unit.

The graphical user interface allows for system operation and data entry and displays information generated from the sensor. This information includes a pressure waveform and readings, such as mean pressure, systolic pressure, diastolic pressure, heart rate and cardiac output. By comparing pressure waveforms before and after deployment of the stent graft, the EndoSure system assists the physician in confirming traditional angiographic findings of successful stent graft placement. During the endovascular repair procedure, pre-exclusion and post-exclusion pressure measurements demonstrate the difference between an aneurysm sac that is exposed to circulation and one that is excluded.

Pre-Exclusion Pressure Waveform

Post-Exclusion Pressure Waveform

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