The Aria CV Pulmonary Hypertension System is designed to mimic the function of healthy pulmonary artery walls and restore compliance to the pulmonary vasculature. By doing so, it may decrease pulse and systolic pressures as well as the pulsatile load on the RV. The system includes an implantable gas-filled Balloon that is introduced percutaneously and anchored in the main PA and an implantable gas Reservoir connected to the Balloon. The Balloon collapses (in systole) and expands (in diastole) with the cardiac cycle, potentially restoring compliance to the PA vasculature.
The Balloon is delivered via a catheter system and secured in the main PA by a nitinol frame (Anchor). The Reservoir is implanted in a subcutaneous pocket created in the underarm or abdominal position. A subcutaneous access port connected to the Reservoir allows for controlled filling and adjustment of gas in the reservoir and balloon to achieve the desired compliance.