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TEL AVIV, Israel, July 16, 2024 /PRNewswire/ -- A patient in Cincinnati has become the first in the United States to receive an innovative system that enables remote monitoring of his heart and congestion status, as well as self-adjustment of diuretics.
以色列特拉维夫,2024年7月16日/PRNewswire/——辛辛那提的一名患者成为美国第一个接受创新系统的患者,该系统能够远程监测他的心脏和充血状态,以及利尿剂的自我调节。
First U.S. Patient Implanted with the V-LAP Left Atrial Pressure Sensor by Vectorious Medical Technologies: A New Treatment Paradigm for Heart Failure Patients
矢量医学技术首次植入V-LAP左心房压力传感器的美国患者:心力衰竭患者的新治疗范例
Vectorious Medical Technologies Ltd. developed a miniature pressure sensor that is implanted within the heart via standard minimally invasive transvenous catheterization. The sensor measures Left Atrial Pressure (LAP), the earliest and most accurate indicator of fluid overload and congestion status.
Vectorious Medical Technologies Ltd.开发了一种微型压力传感器,可通过标准的微创经静脉导管植入心脏。该传感器测量左心房压力(LAP),这是液体超负荷和充血状态的最早和最准确的指标。
The system supports a scalable, physician-directed patient self-management approach, allowing heart failure (HF) patients to take an active role in managing their disease. By using the V-LAP system, patients can better understand their disease and adjust diuretics, daily activities, and fluid volume accordingly..
该系统支持可扩展的,医生指导的患者自我管理方法,允许心力衰竭(HF)患者在管理疾病中发挥积极作用。通过使用V-LAP系统,患者可以更好地了解自己的疾病,并相应地调整利尿剂,日常活动和液体量。。
The first V-LAP implantation in the United States was performed by Sitaramesh Emani, MD, Director of Heart Failure Clinical Trials at The Christ Hospital in Cincinnati, Ohio. To date, 56 V-LAP implantations have been performed, resulting in more than 40,000 days of LAP monitoring. This study, together with the ongoing clinical program in Europe and Israel, will further inform an upcoming U.S.
俄亥俄州辛辛那提基督医院心力衰竭临床试验主任Sitaramesh Emani医学博士在美国进行了第一次V-LAP植入。迄今为止,已经进行了56次V-LAP植入,导致超过40000天的LAP监测。这项研究以及欧洲和以色列正在进行的临床计划将进一步为即将到来的美国。
pivotal trial. .
关键试验。。
'The successful first U.S. V-LAP implantation represents a pivotal moment in heart failure management. By integrating real-time left atrial pressure monitoring into patient care, we are on the cusp of a transformative shift towards more proactive, personalized treatment strategies. This innovative approach aims to improve patient outcomes through a reduction in hospitalizations and enhancement of overall quality of life for heart failure patients, but will do so by empowering patients to actively manage their own care.
“美国第一次成功的V-LAP植入代表了心力衰竭管理的关键时刻。通过将实时左心房压力监测整合到患者护理中,我们正处于向更积极,个性化治疗策略转变的关键时刻。这种创新方法旨在通过减少住院率和提高心力衰竭患者的整体生活质量来改善患者的预后,但将通过授权患者积极管理自己的护理来实现。
The data collected from the VECTOR-HF IIb trial will be instrumental in moving our field forward'. Said Dr. Sitaramesh Emani.Initial studies of the V-LAP system, which were recently published in the European Journal of Heart Failure, have shown promising results. During 85% of the overall follow-up duration (26.98 patient-years, 9,593 LAP monitoring days), patient self-management alone, with no physician intervention, was sufficient to keep HF patients without congestion and within safe LAP ranges.
从VECTOR-HF IIb试验中收集的数据将有助于推动我们的领域向前发展”。Sitaramesh Emani博士说。最近发表在《欧洲心力衰竭杂志》上的V-LAP系统的初步研究显示了有希望的结果。在85%的总体随访时间(26.98患者年,9593圈监测日)内,仅患者自我管理,无需医生干预,足以使HF患者无充血且处于安全圈范围内。
This resulted in a significant decrease in the rate of HF-related hospitalizations and a notable improvement in quality of life, based on the 6-minute walk distance and the Kansas City Cardiomyopathy Questionnaire.Eyal Orion, MD, co-founder and CEO of Vectorious, said, 'We look forward to expanding our clinical activities in the U.S.
根据6分钟步行距离和堪萨斯城心肌病问卷调查,这导致HF相关住院率显着下降,生活质量显着改善。Vectorious联合创始人兼首席执行官、医学博士EyalOrion说,“我们期待着在美国扩大我们的临床活动。
and work closely with physicians, nurses, FDA, and our partners towards a pivotal trial. Recent data published in JAMA Cardiology suggests recent plateaus or reversals after long-standing declines in cardiovascular mortality, particularly for HF related mortality in the U.S. between 1999 and 2021. I strongly believe that the technology and Treatment paradigm we develop have the potential to reverse this concerning trend, and our te.
并与医生、护士、FDA和我们的合作伙伴密切合作,进行关键性试验。最近发表在《美国医学会心脏病学》上的数据表明,心血管死亡率长期下降后,特别是1999年至2021年间美国与心衰相关的死亡率,最近出现了平稳或逆转。我坚信,我们开发的技术和治疗范式有可能扭转这一令人担忧的趋势,我们的te。