Aria CV, Inc, a developer of medical devices treating pulmonary hypertension announced the first patient was implanted with the Gen 2 Aria CV Pulmonary Hypertension System as part of the ASPIRE PH clinical trial at Ascension St. Vincent Cardiovascular Research Institute in Indianapolis, Indiana. The implant was completed on February 14, 2024, by Drs. Ashwin Ravichandran and Scott Hittinger.
The Aria CV Pulmonary Hypertension System is an implantable gas-filled balloon that is introduced percutaneously and functions in the main pulmonary artery to alleviate the excessive workload on the right heart that results in right heart failure. Aria’s device is designed to restore the benefits of a healthy pulmonary artery by reducing cardiac workload and enhancing blood flow through the lungs.
“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 lifechanging for thousands of patients with pulmonary hypertension.”
The ASPIRE PH trial is a feasibility study assessing the initial safety, tolerability, and efficacy of the Aria System under Food and Drug Administration’s (FDA) Early Feasibility Study Program. This program is intended to expedite development of novel medical devices.
“We are proud to have performed the first implant of this novel device, as it offers an alternative treatment for patients who remain significantly impacted by right heart dysfunction related to pulmonary hypertension, which has limited approved therapy options,” said Dr. Ashwin Ravichandran of Ascension St. Vincent Hospital Cardiovascular Institute, one of the surgeons who performed the procedure.