Vollmers, K., Scandurra, J. orcid.org/0009-0004-4014-6781, Woolley, J.R. et al. (6 more authors) (2025) Development of a novel, pulmonary endovascular device to treat patients with pulmonary hypertension. Pulmonary Circulation, 15 (3). e70131. ISSN: 2045-8940
Abstract
Pulmonary hypertension (PH) carries a poor prognosis and a high mortality. Loss of pulmonary arterial compliance (PAC) plays a significant role in the development of PH and is an early predictor of mortality. Currently, there are no therapeutic options to overcome the loss of PAC. Aria CV (Saint Paul, MN) has developed a device to augment PAC. The device consists of a 20-cc balloon and anchor that can be implanted in the pulmonary artery using a minimally invasive procedure, a catheter, and a gas reservoir. Computed tomography imaging of 46 patients from the ASPIRE database and cadaver studies (n = 7) were used to ascertain device fit and optimize surgical procedure. Aria CV devices (n = 6) were tested for simulated use, durability, and PAC augmentation. Animal studies were conducted to demonstrate device safety in the deflated state (n = 9), and gas embolism due to simulated balloon rupture (n = 5). A chronic bovine model of PH was used to demonstrate PAC augmentation (n = 3). Chronic animal studies (n = 8, 30-days) were conducted to demonstrate long-term device safety and biocompatibility per ISO 10993 standards. In-silico fit and cadaver studies demonstrated that the device could be successfully implanted in the PA for a wide range of patients. In vitro and bovine models of PH demonstrated that the chronic Aria CV device enhanced PAC by > 0.4 ml/mmHg, which matched the PAC enhancement observed in 28 human patients with a short-term Aria CV device. The device passed all required durability, safety, and biocompatibility testing and is enrolling patients in a Food and Drug Administration (FDA) approved clinical trial (ASPIRE PH, NCT04555161).
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2025 The Authors. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. http://creativecommons.org/licenses/by-nc/4.0/ |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine and Population Health |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 05 Aug 2025 09:57 |
Last Modified: | 05 Aug 2025 09:57 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1002/pul2.70131 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:230000 |