Development of a Novel, Pulmonary Endovascular Device to Treat Patients With Pulmonary Hypertension
Karl Vollmers, John Scandurra, Joshua R. Woolley, Guruprasad A. Giridharan, Alexander M. K. Rothman, Marc Pritzker, E. Kenneth Weir, Christian Gerges, Irene Lang
https://doi.org/10.1002/pul2.70131
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).