MINNEAPOLIS, Jan. 3, 2024 /PRNewswire/ -- Cardionomic, Inc., a Minneapolis medical device company, is pleased to announce the completion of enrollment in both their STIM-ADHF and STOP-ADHF pilot studies. Both studies were designed to evaluate the safety and performance of the Cardiac Pulmonary Nerve Stimulation (CPNS™) System in patients suffering from Acute Decompensated Heart Failure (ADHF), defined as new or worsening symptoms of heart failure.

明尼阿波利斯，2024年1月3日/PRNewswire/--明尼阿波利斯医疗器械公司Cardionomic，Inc.很高兴宣布完成STIM-ADHF和STOP-ADHF试点研究。两项研究均旨在评估心肺神经刺激（CPNS）的安全性和性能™) 急性失代偿性心力衰竭（ADHF）患者的系统，定义为心力衰竭的新症状或恶化症状。

Thirty-five (35) patients were treated with the CPNS System in Hungary, Poland, Slovakia, Panama, Belgium, The Netherlands, and the United States. Data from the two studies will be pooled, with results from that analysis planned for publication in early 2024.  .

在匈牙利，波兰，斯洛伐克，巴拿马，比利时，荷兰和美国，有35名患者接受了CPNS系统治疗。这两项研究的数据将汇集在一起，该分析的结果计划于2024年初发表。。

Cardionomic's treatment is founded on the principle that autonomic nerve stimulation improves the patient's clinical condition through a triggered rebalancing of the autonomic system, shifting it from a maladaptive state into a cycle that improves the patient beyond CPNS therapy duration. The Cardionomic CPNS System is comprised of a stimulation console and an endovascular catheter that delivers targeted stimulation to the cardiac plexus located in the right pulmonary artery..

Cardionomic的治疗基于以下原则：自主神经刺激通过触发自主神经系统的重新平衡来改善患者的临床状况，将其从适应不良状态转变为改善患者CPNS治疗持续时间以外的周期。心脏CPNS系统由刺激控制台和血管内导管组成，该导管可向位于右肺动脉的心丛提供靶向刺激。。

'This is a significant milestone for Cardionomic, and more importantly for patients suffering from acute decompensated heart failure. The preliminary results from the STIM-ADHF and STOP-ADHF studies suggest that CPNS therapy may address the large unmet need for alternative, and more effective, treatment options for patients hospitalized for heart failure,' said Steve Goedeke, President and Chief Executive Officer of Cardionomic, Inc..

“这是心脏病学的一个重要里程碑，更重要的是对于患有急性失代偿性心力衰竭的患者。Cardionomic，Inc.总裁兼首席执行官史蒂夫·戈德克（SteveGoedeke）说，STIM-ADHF和STOP-ADHF研究的初步结果表明，CPNS治疗可能会解决因心力衰竭住院患者对替代和更有效治疗选择的大量未满足需求。。

'Despite numerous advancements in the treatment of chronic heart failure, therapies to treat ADHF remain limited, especially for those patients who remain congested despite the use of IV diuretics. Such patients have significant disruptions that leave them at high risk for poor outcomes, but unfortunately, current strategies to treat these patients inadequately address the underlying pathophysiology,' said Dr.

“尽管在慢性心力衰竭的治疗方面取得了许多进展，但治疗ADHF的疗法仍然有限，特别是对于那些尽管使用静脉利尿剂仍然充血的患者。这些患者有严重的中断，使他们处于不良预后的高风险中，但不幸的是，目前治疗这些患者的策略没有充分解决潜在的病理生理学问题。

Sitaramesh Emani, Research Director for Advanced Heart Failure Trials at the Christ Hospital Health Network in Cincinnati, Ohio. 'By stimulating the cardiac autonomic nervous system, CPNS therapy can rebalance parasympathetic/sympathetic disruptions, which can lead to meaningful improvement in acute heart failure at a fundamental level, and perhaps have a lasting impact beyond the ADHF event.'  .

俄亥俄州辛辛那提基督医院健康网络（ChristHospital Health Network）高级心力衰竭试验研究主任西塔拉梅什·埃马尼（SitarameshEmani）说通过刺激心脏自主神经系统，CPNS治疗可以重新平衡副交感神经/交感神经中断，这可以在基础水平上导致急性心力衰竭的有意义的改善，并且可能在ADHF事件之外产生持久的影响。”。

About Acute Decompensated Heart Failure Acute decompensated heart failure (ADHF) is defined as the sudden or gradual onset of heart failure signs or symptoms. These include severe breathlessness, rapid weight gain, and fluid build-up in the lungs and around the body. The condition requires a doctor's care, which leads to unplanned office appointments, emergency room visits, hospitalization, and readmission.

关于急性失代偿性心力衰竭急性失代偿性心力衰竭（ADHF）定义为突然或逐渐发作的心力衰竭体征或症状。这些包括严重的呼吸困难，体重迅速增加，肺部和身体周围的液体积聚。这种情况需要医生的护理，这会导致意外的办公室预约，急诊室就诊，住院和再入院。

Inpatient care for these patients is costly, accounting for about 60% of total heart failure expenditures..

这些患者的住院治疗费用昂贵，约占心力衰竭总支出的60%。。

About Cardionomic, Inc. Cardionomic, Inc. is a privately held U.S. company that designs and produces devices to address heart failure. For more information on the company and its products, please visit www.cardionomicinc.com

关于Cardionomic，Inc.Cardionomic，Inc.是一家美国私营公司，设计和生产治疗心力衰竭的设备。有关公司及其产品的更多信息，请访问www.cardionomicinc.com

The CPNS System is an investigational device and is limited by Federal (or United States) Law to investigational use.

CPNS系统是一种研究设备，受联邦（或美国）法律限制用于研究。

SOURCE Cardionomic, Inc.

SOURCE Cardionomic公司。