The eLym system. [Image courtesy of WhiteSwell]

。[图片由WhiteSwell提供]

WhiteSwell

Whiteswell

today announced positive data from 21 patients treated in a trial evaluating its eLym system for fluid removal.

今天公布了21名患者的积极数据，这些患者在一项评估其eLym系统清除液体的试验中接受了治疗。

The company also announced FDA breakthrough device designation for the system. The agency also accepted it into its

该公司还宣布了FDA为该系统指定的突破性设备。该机构还将其纳入其

Total Product Lifecycle Advisory Program (TAP).

产品全生命周期咨询计划（TAP）。

Dr. Jan Biegus presented the data at the

Jan Biegus博士在

Technology and Heart Failure Therapeutics (THT) meeting in

技术与心力衰竭治疗（THT）会议

Boston. Biegus serves as deputy scientific director at the Institute of Heart Diseases at Wroclaw Medial University in Poland.

波士顿。比格斯是波兰弗罗茨瓦夫医科大学心脏病研究所的副科学主任。

Galway, Ireland-based WhiteSwell designed eLym to treat acute decompensated heart failure (ADHF). The minimally invasive, catheter-based system aims to facilitate the removal of excess interstitial fluid from tissues and organs. It achieves this by supporting the overwhelmed lymphatic system in draining fluid for patients with ADHF..

爱尔兰戈尔韦的WhiteSwell设计了eLym来治疗急性失代偿性心力衰竭（ADHF）。。它通过支持ADHF患者排出液体中不堪重负的淋巴系统来实现这一目标。。

eLym deploys in the left internal juglar and innominate veins, near where the lymphatic system’s thoracic duct connects. It creates a low-pressure zone, facilitating fluid drainage in conjunction with intravenous diuretics.

eLym部署在左侧颈内静脉和无名静脉中，靠近淋巴系统胸导管的连接处。它产生一个低压区，与静脉利尿剂一起促进液体引流。

“We are encouraged by the clinical results as more patients are treated with the eLym System. WhiteSwell is entering an important phase as we expand our clinical trial sites and look ahead to a randomized controlled trial in the U.S. and other countries,” said Eamon Brady, WhiteSwell CEO. “By supporting the lymphatic system to drain interstitial tissues and organs in conjunction with diuretic therapy, we hope to break the cycle of repeated heart failure hospitalizations for people with ADHF and improve patient outcomes.” .

Whitewell首席执行官伊蒙·布雷迪（EamonBrady）表示：“随着更多患者接受eLym系统治疗，我们对临床结果感到鼓舞。随着我们扩大临床试验地点，并期待在美国和其他国家进行随机对照试验，Whitewell正进入一个重要阶段。”。“通过支持淋巴系统排出间质组织和器官以及利尿剂治疗，我们希望打破ADHF患者反复心力衰竭住院的循环，改善患者预后。”。

A look at the findings from the WhiteSwell study

看看WhiteSwell研究的发现

WhiteSwell

Whiteswell

previously reported six-month early feasibility data

先前报告的六个月早期可行性数据

from nine patients treated with eLym in late 2023. The new data expands to a larger cohort of 21 hospitalized patients. They received eLym therapy in conjunction with diuretic therapy, with investigators following them through 90 days.

来自2023年末接受eLym治疗的9名患者。新数据扩展到21名住院患者的更大队列。他们接受了eLym治疗和利尿剂治疗，研究人员对他们进行了90天的随访。

Investigators reported successful deployment in all 21 patients in the cohort. Patients who underwent eLym therapy plus loop diuretic lost a mean of 10.7 lbs from baseline to hospital discharge. Every patient lost weight and demonstrated resolution or reduction of peripheral edema and othopnea.

研究人员报告称，该队列中的所有21名患者均成功部署。接受eLym治疗加袢利尿剂的患者从基线到出院平均减轻了10.7磅。每位患者体重减轻，并表现出外周水肿和呼吸困难的消退或减轻。

According to WhiteSwell, patients had stable kidney function during treatment and through discharge. One patient experienced a serious procedure-, device- or therapy-related adverse event. Investigators resolved this prior to discharge. At 90 days, 9.5% of patients experienced rehospitalization for heart failure.

根据WhiteSwell的说法，患者在治疗期间和出院期间肾功能稳定。一名患者经历了严重的手术，设备或治疗相关不良事件。研究人员在出院前解决了这个问题。在90天时，9.5%的患者因心力衰竭再次住院。

The study had no deaths..

。。

The company says its study continues enrolling patients in Europe. It plans for a randomized controlled trial in the U.S., Canada and Europe later this year.

该公司表示，其研究继续在欧洲招募患者。它计划今年晚些时候在美国、加拿大和欧洲进行一项随机对照试验。

“Persistent congestion in acute heart failure patients is associated with a high risk of rehospitalization and death. The lymphatic system is believed to be critical in effectively removing excess fluid from the tissues and organs, yet can be dysfunctional in heart failure patients,” said Biegus. “The eLym system is designed to support lymphatic function during decongestive therapy.

Biegus说：“急性心力衰竭患者持续充血与再住院和死亡的高风险有关。淋巴系统被认为是有效清除组织和器官中多余液体的关键，但心力衰竭患者可能会出现功能障碍。”。“eLym系统旨在支持减充血治疗期间的淋巴功能。

In the first 21 patients treated, all patients lost weight and demonstrated concordant signs of decongestion, while maintaining stable renal function. At 90 days, having just 9.5% of patients rehospitalized for heart failure with no deaths is substantially better than rates we see with standard-of-care diuretics alone, which is quite promising.” .

在接受治疗的前21名患者中，所有患者均体重减轻，并表现出一致的缓解迹象，同时保持了稳定的肾功能。在90天的时间里，只有9.5%的患者因心力衰竭再次住院而没有死亡，这比我们单独使用标准护理利尿剂所看到的情况要好得多，这是非常有希望的。”。