Cordella, which consists of the now PMA-approved Cordella PA Sensor and commercial Cordella™ HF System, enables comprehensive heart failure management in the home using pulmonary artery (PA) pressure, a leading indicator of congestion, and non-invasive vital sign data to improve care decisions.

Cordella由现已获得PMA批准的Cordella PA传感器和商用Cordella™HF系统组成，可使用肺动脉（PA）压力（充血的主要指标）和非侵入性生命体征数据在家中进行全面的心力衰竭管理，以改善护理决策。

Backed by definitive clinical evidence from the PROACTIVE-HF pivotal trial, the company is planning a U.S. launch of Cordella this year.

在PROACTIVE-HF pivotal试验的明确临床证据的支持下，该公司计划今年在美国推出Cordella。

NAPERVILLE, Ill., June 24, 2024 /PRNewswire/ --Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medtech, today announced Premarket Approval (PMA) from the U.S Food and Drug Administration (FDA) of the company's Cordella™ Pulmonary Artery (PA) Sensor System for the treatment of New York Heart Failure (NYHA) class III heart failure patients.

伊利诺伊州纳佩维尔（NAPERVILLE），2024年6月24日/PRNewswire/-Endotronix，Inc.，一家私营公司，致力于在数字健康和医疗技术的交叉点推进心力衰竭（HF）的治疗，今天宣布美国食品和药物管理局（FDA）对该公司用于治疗纽约心力衰竭（NYHA）III级心力衰竭患者的Cordella™肺动脉（PA）传感器系统进行上市前批准（PMA）。

The Cordella platform is the first and only PA pressure-guided platform to offer comprehensive patient management using daily PA pressure and vital signs from home to guide therapeutic management and improve patient outcomes..

Cordella平台是第一个也是唯一一个PA压力引导平台，可使用家庭的日常PA压力和生命体征提供全面的患者管理，以指导治疗管理并改善患者预后。。

'This approval is very exciting and has the potential to transform care for HF patients.' Dr. Liviu Klein

“这一批准非常令人兴奋，有可能改变HF患者的护理。”Liviu Klein博士

'This approval is very exciting and has the potential to transform care for HF patients. Endotronix's solution provides a more complete clinical picture of the patient, so providers are able to make informed remote care decisions between office visits,' stated Dr. Liviu Klein, Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco and national principal investigator of the PROACTIVE-HF trial.

“这一批准非常令人兴奋，有可能改变HF患者的护理。加州大学旧金山分校晚期心力衰竭、机械循环支持、肺动脉高压和心脏移植科科长兼PROVATIVE-HF试验国家首席研究员利维乌·克莱因博士表示，Endotronix的解决方案为患者提供了更完整的临床情况，因此提供者能够在办公室就诊之间做出明智的远程护理决定。

'PROACTIVE-HF demonstrated that with Cordella clinicians achieved more optimal and timely dosing of key HF medications, significantly improving outcomes. In addition, the easy-to-use platform engages patients to drive consistent daily habits and self-awareness of trends to support sustainable lifestyle changes.'.

“PROACTIVE-HF证明，使用Cordella，临床医生实现了关键HF药物的最佳和及时给药，显着改善了结果。。

Cordella is a proactive HF management platform that delivers daily PA pressure and other vital data via an implantable sensor and user-friendly, non-invasive health tools, respectively, to a managing HF clinician for remote patient care. This information guides clinical decision-making and medication dosing while enhancing the adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes.

Cordella是一个主动式HF管理平台，通过植入式传感器和用户友好的非侵入性健康工具分别向管理HF的临床医生提供每日PA压力和其他重要数据，以进行远程患者护理。这些信息指导临床决策和药物剂量，同时加强指南指导药物治疗（GDMT）的采用，以减少充血并改善结果。

Regulatory approval was based on the PROACTIVE-HF trial, which demonstrated a markedly low 0.159 rate of heart failure hospitalization and all-cause mortality at 6 months..

监管部门的批准是基于PROVICE-HF试验，该试验显示6个月时心力衰竭住院率和全因死亡率显着降低0.159。。

In addition, Cordella enables:

此外，Cordella还支持：

Seated PA pressure measurements, preferred by most patients, with a handheld reader.

大多数患者首选手持读取器进行坐姿PA压力测量。

Patient visibility into key health trends to support healthy lifestyle changes.

。

Secure messaging on a tablet between the clinical team, patient, and caregiver to support remote care.

确保临床团队、患者和护理人员之间在平板电脑上的信息安全，以支持远程护理。

Reimbursement for implantation and ongoing management through existing reimbursement pathways.

通过现有的报销途径对植入和持续管理进行报销。

'At Endotronix, we firmly believe that innovation can drive patient care excellence in the home and ultimately change outcomes for patients with heart failure, one of the largest cost categories in healthcare. The FDA's approval validates this foundational belief and is a major milestone for our company and the field of HF management,' commented Harry Rowland, CEO and co-founder of Endotronix.

“在Endotronix，我们坚信创新可以推动家庭患者护理的卓越，并最终改变心力衰竭患者的预后，心力衰竭是医疗保健中最大的成本类别之一。Endotronix首席执行官兼联合创始人哈里·罗兰（HarryRowland）评论道，FDA的批准验证了这一基本信念，是我们公司和HF管理领域的一个重要里程碑。

'With this approval, we will deliver proactive, comprehensive care that extends optimal HF therapeutic management to more patients, keeping them out of the hospital and living more fulfilling lives.'.

“有了这一批准，我们将提供积极、全面的护理，为更多患者提供最佳的HF治疗管理，使他们远离医院，过上更加充实的生活。”。

Endotronix will launch Cordella in the U.S. later this year. The company also shared that they have submitted a dossier for CE Mark review and expect a decision on European market access in 2025.

Endotronix将于今年晚些时候在美国推出Cordella。该公司还透露，他们已经提交了一份CE标志审查档案，预计2025年将对欧洲市场准入作出决定。

About Endotronix

关于Endotronix

Endotronix innovates at the intersection of medtech and digital health to improve care for people living with heart failure (HF). The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella Sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures the leading indicator of congestion, allowing early, targeted therapy.

Endotronix在medtech和数字健康的交叉点进行创新，以改善心力衰竭（HF）患者的护理。全面的Cordella解决方案能够实现主动的，数据驱动的HF管理，使患者参与，减少和预防充血，并改善结果。Cordella传感器是一种植入式肺动脉（PA）压力传感器，可直接测量充血的主要指标，从而可以进行早期的靶向治疗。

The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions. Combining trended insights, the versatile and scalable Cordella enhances current clinical practice and supports guideline-based care across the entire HF continuum.

Cordella HF系统是一个患者健康管理平台，它结合了来自非侵入性设备的全面生命体征数据，以支持患者临床医生的参与和护理决策。结合趋势的见解，多功能和可扩展的Cordella增强了当前的临床实践，并支持整个HF连续体中基于指南的护理。

Learn more at www.endotronix.com..

Learn more at www.endotronix.com..

In the U.S., the Cordella PA Sensor System is Rx Only. CAUTION: Federal law restricts this device to sale by or on the order of a physician.

在美国，Cordella PA传感器系统仅为Rx。注意：联邦法律限制该设备由医生或根据医生的指示销售。

In Europe, the Cordella PA Sensor System is Exclusively for Clinical Investigation.

。

The Cordella HF System is commercially available in the U.S. and Europe.

Cordella HF系统可在美国和欧洲市场上买到。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警示声明

This press release may contain predictions, estimates, or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

本新闻稿可能包含预测、估计或其他可能被视为前瞻性声明的信息。这种前瞻性陈述并不能保证未来的表现。

View original content to download multimedia:https://www.prnewswire.com/news-releases/endotronix-receives-fda-premarket-approval-of-the-cordella-pa-sensor-system-for-the-treatment-of-heart-failure-302179602.html

查看原始内容以下载多媒体：https://www.prnewswire.com/news-releases/endotronix-receives-fda-premarket-approval-of-the-cordella-pa-sensor-system-for-the-treatment-of-heart-failure-302179602.html

SOURCE Endotronix, Inc.

SOURCE Endotronix公司。