Lungpacer Medical

肺起搏器医疗

today announced positive results from a Phase 1 clinical study evaluating its neurostimulation technology platform.

今天宣布了一项评估其神经刺激技术平台的 1 期临床研究的积极结果。

The STIMULUS trial investigated the application of diaphragm neurostimulation to improve hemodynamic performance in patients on invasive mechanical ventilation. Results demonstrated improvement in hemodynamic performance, according to a news release. Investigators presented findings at the 2025 Transcatheter Heart Therapies (THT) conference..

STIMULUS 试验研究了膈神经刺激在改善接受有创机械通气患者的血流动力学性能方面的应用。据新闻稿称，结果显示血流动力学性能有所改善。研究人员在2025年经导管心脏治疗（THT）会议上展示了研究结果。

Exton, Pennsylvania-based Lungpacer Medical’s trial evaluated its investigational AeroNova system. The company already offers the

总部位于宾夕法尼亚州埃克斯顿的Lungpacer Medical公司对其研究中的AeroNova系统进行了试验评估。该公司已经提供

FDA-approved AeroPace system

FDA批准的AeroPace系统

that delivers neurostimulation via an electrode-containing cardiovascular catheter and a software-controlled system. It delivers periodic phrenic nerve stimulation through the venous catheter. The system contracts and strengthens the diaphragm in patients on mechanical ventilation.

通过含电极的心血管导管和软件控制系统进行神经刺激。它通过静脉导管提供周期性的膈神经刺激。该系统能够收缩并强化使用机械通气患者的膈肌。

The investigational AeroNova system comprises a cardiovascular catheter embedded with stimulating electrodes. It features a software-controlled system that contracts the diaphragm through transvenous prenic nerve neurostimulation. The company designed AeroNova to achieve ventilation using lower positive pressures from the ventilator.

AeroNova 系统包含一个嵌有刺激电极的心血管导管，该系统通过软件控制，利用经静脉膈神经刺激使膈肌收缩。公司设计 AeroNova 的目的是使用来自呼吸机的较低正压实现通气。

This mitigates ventilator-induced injury to the lung, diaphragm, heart and brain of patients on mechanical ventilation..

这减轻了机械通气患者肺部、膈肌、心脏和大脑的呼吸机诱导损伤。

LungPacer said STIMULUS marks a significant milestone in advancing medtech designed to optimize patient care in the ICU. The single-center study aimed to evaluate AeroNova’s safety and effectiveness in patients with acute hypoxemic respiratory failure or post-thoracic surgery respiratory failure.

LungPacer表示，STIMULUS标志着在推进旨在优化ICU患者护理的医疗技术方面迈出了重要的一步。这项单中心研究旨在评估AeroNova在急性低氧性呼吸衰竭或胸部手术后呼吸衰竭患者中的安全性和有效性。

A key outcome focused on measuring how diaphragm activation, when synchronized with mechanical ventilation, could improve cardiovascular function and mitigate the negative hemodynamic effects commonly seen with invasive mechanical ventilation.

一个关键成果集中在测量膈肌激活与机械通气同步时如何改善心血管功能，并减轻通常在侵入性机械通气中看到的负面血液动力学影响。

A look at the Lungpacer study results

查看Lungpacer研究结果

Lungpacer’s study enrolled 19 patients. Of those, 16 underwent a stimulation titration procedure. The majority of patients (12/16, 75%) had pre-existing cardiac dysfunction and exhibited a high incidence of right ventricular dysfunction and/or pulmonary hypertension.

Lungpacer的研究纳入了19名患者，其中16名患者进行了刺激滴定程序。大多数患者（12/16，75%）存在既往心脏功能障碍，并表现出高发的右心室功能障碍和/或肺动脉高压。

Using the AeroPace catheter, investigators safely delivered transvenous bilateral neurostimulation. They used stimulation levels titrated to achieve diaphragm activation, resulting in increasing levels of expiratory occlusion pressure. The study evaluated a range of cardiac outcomes at baseline compared to after treatment..

使用AeroPace导管，研究人员安全地进行了经静脉双侧神经刺激。他们通过调节刺激水平来实现膈肌激活，从而增加呼气阻塞压力。该研究评估了治疗前后的多种心脏指标变化。

Increasing levels of diaphragm neurostimulation led to a significant increase in cardiac index and stroke volume. Lungpacer said this indicates better heart performance and enhanced blood flow. The company also reported overall hemodynamic stability and decreased pulmonary artery pressure.

增加膈神经刺激水平可显著提高心脏指数和每搏输出量。Lungpacer 表示，这表明心脏性能更好，血流量增加。该公司还报告了整体血液动力学稳定性以及肺动脉压降低。

“The study results indicate that diaphragm neurostimulation merits further exploration as a novel therapy to counteract the harmful cardiovascular effects associated with positive pressure ventilation by improving cardiac function and pulmonary hemodynamics,” Lungpacer said. “The study suggests a dose-response relationship, where increasing stimulation correlates with further improvements in cardiac and pulmonary parameters, providing a strong foundation for future investigation.”.

Lungpacer 表示：“研究结果表明，膈神经刺激作为一种新型疗法，能够通过改善心脏功能和肺血流动力学来对抗正压通气带来的有害心血管影响，值得进一步探索。” “研究表明存在剂量反应关系，增加刺激与心脏和肺部参数的进一步改善相关，为未来的研究提供了坚实的基础。”