Aria CV Announces First Patient Successfully Implanted with Second-Generation Pulmonary Hypertension System

Gen 2 System has potential to reduce cardiac workload and enhance blood flow

February 27, 2024 – SAINT PAUL, Minn.–(BUSINESS WIRE)–Aria CV, Inc, a developer of medical devices treating pulmonary hypertension, today 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.

“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”

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.

About Pulmonary Hypertension
Pulmonary hypertension (PH), which impacts up to 70 million people worldwide, is characterized by high blood pressure in the arteries of the lungs, a condition which causes increased workload on the heart, leading to right heart failure. PH can be caused by common conditions such as COPD or left heart failure, and can occur without any identified underlying cause and is considered a progressive deadly disease.

About Ascension St. Vincent
Ascension St. Vincent operates 19 hospitals in addition to a comprehensive network of affiliated joint ventures, medical practices and clinics serving Indiana and employs more than 15,000 associates. Across the state, Ascension St. Vincent provided more than $323 million in community benefit and care of persons living in poverty in Fiscal Year 2022.

Ascension St. Vincent has been serving Indiana for 150 years and is a part of Ascension (www.ascension.org), one of the leading non-profit and Catholic health systems in the United States. Ascension is a faith-based healthcare organization committed to delivering compassionate, personalized care to all, with special attention to persons living in poverty and those most vulnerable. Ascension includes approximately 150,000 associates and 40,000 aligned providers. The national health system operates more than 2,600 sites of care – including 139 hospitals and more than 40 senior living facilities – in 19 states.

About Aria CV, Inc.
Based in St. Paul, Minnesota, Aria is led by Dan Gladney, President and CEO of Aria CV, Inc. Aria was founded in 2010 by Drs. John Scandurra and Karl Vollmers, following development work the two had done at the University of Minnesota. Aria has successfully performed 28 acute first in human clinical cases in Vienna, Austria and is planning to enroll 30 patients in its Early Feasibility Study. For additional information: www.ariacv.com

SOURCE: Aria CV, Inc | Ascension St. Vincent