Implantable Device for Pulmonary Hypertension Reduces Cardiac Workload and Enhances Blood Flow

Image: The flexible, gas-filled balloon is placed in the main pulmonary artery and connected by a catheter to a hollow reservoir (Photo courtesy of Aria CV)

Pulmonary hypertension is a severe, progressive disease affecting as many as 70 million people globally. It develops when the walls of the pulmonary arteries become rigid, losing their ability to stretch adequately to manage blood flow. Normally, the pressure in the pulmonary arteries of a healthy individual is relatively low. However, in patients with pulmonary hypertension, this pressure increases, and the vessel walls thicken and narrow, impeding blood flow and diminishing vessel elasticity with each heartbeat. This leads to heightened pressure and additional strain on the right side of the heart. Now, a novel implantable device can mimic the function of the healthy vessels by restoring compliance to the pulmonary vessels, thus enabling the heart to pump more blood for less energy. These can improve the ability to exercise while reducing the burden on the heart.

Aria CV’s (St. Paul, MN, USA) Pulmonary Hypertension System is an implantable gas-filled balloon that is introduced percutaneously and functions in the main pulmonary artery to reduce the excessive workload on the right heart that can cause right heart failure. The device aims to restore the benefits of a healthy pulmonary artery by reducing cardiac workload and increasing blood flow through the lungs. This novel device offers an alternative treatment for patients who continue to be significantly impacted by right heart dysfunction related to pulmonary hypertension, for which there are limited approved therapy options. The first patient has now been successfully implanted with the Gen 2 Aria CV Pulmonary Hypertension System as part of the ASPIRE PH clinical trial. The ASPIRE PH trial is a feasibility study assessing the initial safety, tolerability, and efficacy of the Aria System under the Food and Drug Administration’s (FDA) Early Feasibility Study Program.

“The successful patient implant of the Gen 2 system is a significant milestone in realizing our mission to improve the lives of those suffering from pulmonary hypertension, a life-threatening disease that can lead to heart failure,” said Dan Gladney, President and CEO of Aria CV. “This procedure is a testament to the dedicated ASPIRE PH team that is providing patients with a novel therapeutic option to treat this deadly condition. If approved, this technology has the potential to be lifesaving and life-changing for thousands of patients with pulmonary hypertension.”