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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.
明尼苏达州圣保罗市(商业新闻短讯)--治疗肺动脉高压的医疗设备开发商Aria CV,Inc今天宣布,作为印第安纳州印第安纳波利斯阿森松圣文森特心血管研究所ASPIRE PH临床试验的一部分,第一名患者植入了第二代Aria CV肺动脉高压系统。
The implant was completed on February 14, 2024, by Drs. Ashwin Ravichandran and Scott Hittinger..
该植入物于2024年2月14日由AshwinRavichandran博士和ScottHittinger博士完成。。
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..
Aria CV肺动脉高压系统是一种植入式充气球囊,经皮引入,在主肺动脉中起作用,以减轻导致右心衰竭的右心过度负荷。Aria的设备旨在通过减少心脏负荷和增强肺部血流来恢复健康肺动脉的益处。。
“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.
丹·格拉德尼(DanGladney)说:“第二代系统的成功植入是实现我们改善肺动脉高压患者生活的重要里程碑,肺动脉高压是一种危及生命的疾病,可导致心力衰竭。”,Aria CV总裁兼首席执行官:“这一过程证明了ASPIRE PH团队的敬业精神,该团队为患者提供了治疗这种致命疾病的新型治疗选择。
If approved, this technology has the potential to be lifesaving and lifechanging for thousands of patients with pulmonary hypertension.”.
如果获得批准,这项技术有可能挽救数千名肺动脉高压患者的生命和改变他们的生活。”。
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.
ASPIRE PH试验是一项可行性研究,根据食品和药物管理局(FDA)的早期可行性研究计划,评估Aria系统的初始安全性,耐受性和有效性。该计划旨在加速新型医疗设备的开发。
“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.
Ascension St.的Ashwin Ravichandran博士说:“我们很骄傲地完成了这种新型装置的首次植入,因为它为仍然受到与肺动脉高压相关的右心功能障碍严重影响的患者提供了替代治疗方法,而肺动脉高压限制了批准的治疗选择。”。
Vincent Hospital Cardiovascular Institute, one of the surgeons who performed the procedure..
文森特医院心血管研究所是进行该手术的外科医生之一。。
About Pulmonary Hypertension
关于肺动脉高压
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..
肺动脉高压(PH)影响全球7000万人,其特征是肺动脉高压,这种情况会导致心脏工作量增加,导致右心衰竭。PH可能由COPD或左心衰竭等常见疾病引起,并且可能在没有任何确定的潜在原因的情况下发生,被认为是一种进行性致命疾病。。
About Ascension St. Vincent
关于阿森松岛圣文森特
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..
阿森松圣文森特拥有19家医院,以及为印第安纳州服务的附属合资企业、医疗机构和诊所的综合网络,拥有15000多名员工。2022财政年度,阿森松森圣文森特为全州贫困人口提供了超过3.23亿美元的社区福利和护理。。
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.
阿森松岛圣文森特为印第安纳州服务了150年,是阿森松岛(www.Ascension.org)的一部分,阿森松岛是美国领先的非营利和天主教卫生系统之一。Ascension是一个基于信仰的医疗保健组织,致力于为所有人提供富有同情心的个性化护理,特别关注生活在贫困中的人和最脆弱的人。
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..
Ascension包括大约150000名员工和40000名合作供应商。国家卫生系统在19个州运营着2600多个护理场所,其中包括139家医院和40多家老年生活设施。。
About Aria CV, Inc.
关于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.
Aria总部位于明尼苏达州圣保罗市,由Aria CV,Inc.总裁兼首席执行官丹·格拉德尼(DanGladney)领导。Aria于2010年由约翰·斯坎杜拉(JohnScandurra)博士和卡尔·沃尔默斯(KarlVollmers)博士在明尼苏达大学(University of Minnesota)完成开发工作后成立。Aria在奥地利维也纳成功完成了28例急性首次人类临床病例,并计划在其早期可行性研究中招募30名患者。
For additional information: www.ariacv.com.
有关更多信息,请访问www.ariacv.com。