Vollmers Karl, Scandurra John, Woolley Joshua R, Giridharan Guruprasad A, Rothman Alexander M K, Pritzker Marc, Weir E Kenneth, Gerges Christian, Lang Irene
Aria CV, Inc Saint Paul Minnesota USA.
University of Louisville Louisville Kentucky USA.
Pulm Circ. 2025 Jul 29;15(3):e70131. doi: 10.1002/pul2.70131. eCollection 2025 Jul.
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 ( = 7) were used to ascertain device fit and optimize surgical procedure. Aria CV devices ( = 6) were tested for simulated use, durability, and PAC augmentation. Animal studies were conducted to demonstrate device safety in the deflated state ( = 9), and gas embolism due to simulated balloon rupture ( = 5). A chronic bovine model of PH was used to demonstrate PAC augmentation ( = 3). Chronic animal studies ( = 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).
肺动脉高压（PH）预后不良且死亡率高。肺动脉顺应性（PAC）丧失在PH的发展中起重要作用，并且是死亡率的早期预测指标。目前，尚无克服PAC丧失的治疗选择。Aria CV公司（明尼苏达州圣保罗）开发了一种增加PAC的装置。该装置由一个20立方厘米的球囊和锚定器组成，可通过微创手术、导管和储气罐植入肺动脉。使用来自ASPIRE数据库的46例患者的计算机断层扫描成像和尸体研究（n = 7）来确定装置的适配性并优化手术程序。对Aria CV装置（n = 6）进行了模拟使用、耐用性和PAC增加测试。进行动物研究以证明装置在放气状态下的安全性（n = 9），以及模拟球囊破裂导致的气体栓塞（n = 5）。使用慢性牛PH模型来证明PAC增加（n = 3）。根据ISO 10993标准进行慢性动物研究（n = 8，30天）以证明装置的长期安全性和生物相容性。计算机模拟适配和尸体研究表明，该装置可成功植入广泛患者的肺动脉。PH的体外和牛模型表明，慢性Aria CV装置可使PAC增加>0.4毫升/毫米汞柱，这与28例使用短期Aria CV装置的人类患者中观察到的PAC增加相匹配。该装置通过了所有必需的耐用性、安全性和生物相容性测试，并且正在一项美国食品药品监督管理局（FDA）批准的临床试验（ASPIRE PH，NCT04555161）中招募患者。
