Imperative Care, Inc. today announced positive efficacy and safety results from the pivotal SYMPHONY-PE Trial (NCT06062329) evaluating the company’s Symphony® Thrombectomy System in the treatment of acute pulmonary embolism (PE). Results of the SYMPHONY-PE Trial were presented in a late-breaking session at The PERT Consortium® 2025 11th Annual Pulmonary Embolism (PE) Scientific Symposium in San Diego, CA, and published in Circulation: Cardiovascular Interventions in a paper titled “A Prospective Multicenter IDE Study of the Next-Generation Precision Aspiration Thrombectomy System for Intermediate-Risk Pulmonary Embolism: The SYMPHONY-PE Trial.”.

Imperative Care, Inc. 今天宣布了关键的 SYMPHONY-PE 试验（NCT06062329）的积极有效性和安全性结果，该试验评估了公司 Symphony® 血栓切除系统在治疗急性肺栓塞（PE）中的应用。SYMPHONY-PE 试验的结果在加利福尼亚州圣地亚哥举行的 PERT 联盟® 2025 年第 11 届年度肺栓塞（PE）科学研讨会的一个最新突破性会议环节中公布，并在《循环：心血管介入》杂志上发表，论文题目为《新一代精准抽吸血栓切除系统治疗中危肺栓塞的前瞻性多中心 IDE 研究：SYMPHONY-PE 试验》。

In the trial, Symphony demonstrated a strong safety profile, high efficacy, and procedural efficiency. Notably, there were no device-related serious adverse events (SAE), with marked clot-burden reduction, short device-use time, and minimal blood loss.

在试验中，Symphony 展现了良好的安全性、高效性和操作效率。值得注意的是，没有任何与设备相关的严重不良事件（SAE），并且显著减少了血栓负担、缩短了设备使用时间、并将血液损失降到最低。

The prospective Investigational Device Exemption (IDE) trial evaluated 109 patients with acute intermediate-risk PE across 17 U.S. institutions. The trial was led by National Co-Principal Investigators Vivian L. Bishay, M.D., Associate Professor in the Department of Diagnostic, Molecular and Interventional Radiology at the Mount Sinai Health System and presenter of the late-breaking results at PERT, and Sripal Bangalore, M.D., M.H.A., Professor in the Department of Medicine at NYU Grossman School of Medicine and lead author of the peer-reviewed paper..

前瞻性研究设备豁免（IDE）试验评估了来自美国17家机构的109名急性中危肺栓塞（PE）患者。该试验由全国联合首席研究员 Vivian L. Bishay 医学博士和 Sripal Bangalore 医学博士、医学硕士共同领导。Vivian L. Bishay 博士是西奈山卫生系统诊断、分子与介入放射科的副教授，并在PERT会议上展示了这项突破性结果；Sripal Bangalore 博士是纽约大学格罗斯曼医学院医学系教授，并且是同行评审论文的第一作者。

“The trial results demonstrated significant improvements in right ventricle–to–left ventricle (RV/LV) ratio, systolic and mean pulmonary artery pressures (PAP), and clot burden, with no device-related SAE and no mortality reported at 30 days,” said Dr. Bishay. “These findings represent clinically meaningful progress in PE treatment, underscoring the device’s excellent safety profile.

“试验结果表明，右心室与左心室 (RV/LV) 比率、收缩期和平均肺动脉压力 (PAP) 以及血栓负荷均有显著改善，且30天内未报告与设备相关的严重不良事件 (SAE) 和死亡率，”毕沙伊博士说道。“这些发现代表了肺栓塞 (PE) 治疗中具有临床意义的进展，突显了该设备出色的安全性。”

The ability to bring a large-bore catheter directly to the clot and safely deliver continuous aspiration marks an emerging paradigm shift in PE intervention. I look forward to the device’s continued impact in my practice.”.

将大口径导管直接带到血栓处并安全地进行持续抽吸的能力，标志着PE介入领域正在发生一种新兴的范式转变。我期待该设备在我的实践中继续发挥作用。"

“Rapid thrombus removal using large-bore mechanical thrombectomy has the potential to improve patient hemodynamics, relieve right-heart strain, and reduce short-term morbidity and mortality in PE,” said Dr. Bangalore. “The excellent safety and efficacy demonstrated in this trial, together with short device-use times and minimal blood loss, underscore Symphony’s ability to address a critical unmet need by combining the advantages of large-bore continuous aspiration with the exceptional safety of real-time vacuum control.”.

“使用大口径机械血栓切除术快速去除血栓有潜力改善肺栓塞患者的血液动力学，减轻右心压力，并降低短期发病率和死亡率，”班加罗尔博士说。“这项试验中展现出的出色安全性和有效性，加上设备使用时间短和失血量极少，突显了Symphony通过结合大口径连续抽吸的优势与实时真空控制的卓越安全性，满足了一项关键的未满足需求。”

The trial met its pre-specified primary efficacy and safety endpoints, with results demonstrating:

该试验达到了预先设定的主要疗效和安全性终点，结果表明：

Efficacy: the core laboratory independently adjudicated a mean RV/LV reduction of 0.44 ± 0.42 from baseline to 48 hours. The lower bound of the 97.5 % confidence interval (0.36) exceeded the prespecified performance goal of > 0.20 (p < 0.001).

疗效：核心实验室独立判定右心室/左心室比值从基线到48小时平均减少0.44 ± 0.42。97.5%置信区间的下限（0.36）超过了预设的性能目标> 0.20（p < 0.001）。

Safety: the independent safety board adjudicated the major adverse event (MAE) rate, a composite of all-cause major bleeding, device-related deaths, and device-related SAE rate within 48 hours of the procedure, at 0.9 % (1/109). The 97.5% upper confidence interval bound (5.7 %) was significantly lower than the 15% performance goal (p < 0.001)..

安全性：独立安全委员会裁定，主要不良事件（MAE）率为 0.9%（1/109），包括所有原因导致的主要出血、与设备相关的死亡以及在手术后 48 小时内与设备相关的严重不良事件（SAE）的综合指标。其 97.5% 的置信区间上限（5.7%）显著低于 15% 的性能目标（p < 0.001）。

“Symphony demonstrated an exceptional ability to deliver immediate and sustained objective and subjective improvements, achieving a 12 mmHg reduction in systolic pulmonary artery pressure and a 7 mmHg reduction in mean pulmonary artery pressure after aspiration, along with a 38.4% decrease in clot burden at 48 hours – all with a notably short device-use time and no safety concerns,” said Dr.

“Symphony 展现了出色的即时和持续客观及主观改善能力，在抽吸后使收缩期肺动脉压降低 12 毫米汞柱，平均肺动脉压降低 7 毫米汞柱，并在 48 小时内血栓负荷减少了 38.4%——所有这些均在极短的设备使用时间内实现，且没有任何安全隐患，”博士说道。

Dana Tomalty, M.D., Peripheral and Neuro Interventional Radiologist at Huntsville Hospital and the highest enroller in the trial. “These results appear to set a new benchmark for efficiency and safety in PE intervention. I am eager to bring this technology into routine clinical practice to improve outcomes for patients with acute PE.”.

达娜·托马尔蒂医学博士，亨茨维尔医院的周围和神经介入放射科医生，也是该试验中招募人数最多的医生。“这些结果似乎为肺栓塞介入治疗的效率和安全性设定了新的基准。我渴望将这项技术引入常规临床实践，以改善急性肺栓塞患者的治疗效果。”

“Symphony introduces a new category in venous thromboembolism (VTE) treatment with Pulse Thrombectomy – the unique combination of a large-bore catheter with powerful, continuous vacuum delivered closer to the clot. This technology, paired with a streamlined procedural technique, enables physicians to remove more clot in less time,” said Doug Boyd, SVP and General Manager of Imperative Care’s Vascular business.

“Symphony通过脉冲血栓切除术在静脉血栓栓塞症（VTE）治疗中引入了一个新类别——大口径导管与强大、持续的真空相结合，更靠近血栓。这项技术与简化的手术操作技术相结合，使医生能够在更短的时间内清除更多血栓，”Imperative Care血管业务高级副总裁兼总经理Doug Boyd表示。

“We remain committed to building robust clinical evidence that validates our technologies and extends Symphony’s impact so more patients can receive life-saving care. We are deeply grateful to the patients, investigators, and clinical sites who helped make Symphony available across the U.S.”.

“我们依然致力于建立强有力的临床证据，以验证我们的技术，并扩大Symphony的影响，使更多患者能够获得挽救生命的护理。我们深切感谢帮助Symphony在美国各地推广的患者、研究人员和临床站点。”

About the Symphony Thrombectomy System

关于Symphony血栓切除系统

The Symphony Thrombectomy System is an aspiration catheter system engineered to deliver more efficient and effective clot removal in patients with venous thromboembolism (VTE). Symphony uniquely combines large-bore power with precise deep vacuum, giving physicians full control to remove more clot in less time.

Symphony血栓切除系统是一种抽吸导管系统，旨在为静脉血栓栓塞症（VTE）患者提供更高效和有效的血栓清除。Symphony独特地将大口径功率与精确的深度真空相结合，使医生能够完全掌控，在更短的时间内清除更多血栓。

By delivering continuous deep vacuum closer to the clot, Symphony generates a Deep Pulse, a powerful pulse of aspiration that provides greater clot removal force compared to each of a syringe-based and tubing-based system1 and minimal blood loss2. The system includes 16F and 24F catheters for smooth tracking, stability, and telescoping to reach distal anatomy; ProHelix® Mechanical Assist designed to facilitate clot ingestion when needed; the Symphony 24F Advance® Long Dilator for navigating through tortuous anatomy; and the Imperative Care Generator, one of the most powerful aspiration pumps available on the market1.

通过产生接近血栓的持续深度真空，Symphony 生成了深度脉冲 (Deep Pulse)，这是一种强大的抽吸脉冲，与基于注射器和基于管道的系统相比，能够提供更大的血栓清除力，并且减少血液流失。该系统包括 16F 和 24F 导管，可实现平稳跟踪、稳定性以及延伸至远端解剖结构；ProHelix® 机械辅助装置旨在必要时促进血栓摄取；Symphony 24F Advance® 长扩张器用于穿越迂曲的解剖结构；以及市场上最强大的抽吸泵之一——Imperative Care Generator。

The Symphony Thrombectomy System received 510(k) clearance from the FDA for the treatment of pulmonary embolism on August 28, 2025..

2025年8月28日，Symphony血栓切除系统获得FDA的510(k)许可，用于治疗肺栓塞。

For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: http://bit.ly/3pAaUlw

有关完整的产品信息，包括适应症、禁忌症、警告、注意事项和不良事件，请访问：http://bit.ly/3pAaUlw

About Imperative Care, Inc.

关于Imperative Care公司

Imperative Care is a commercial-stage medical technology company researching and developing connected innovations to elevate care for people affected by devastating vascular diseases such as stroke and pulmonary embolism. The company is focused on addressing specific gaps in treatment and care to make an impact across the entire patient journey.

Imperative Care是一家处于商业化阶段的医疗技术公司，致力于研究和开发互联创新技术，以提升受严重血管疾病（如中风和肺栓塞）影响患者的护理水平。该公司专注于解决治疗和护理中的特定缺口，力求在整个患者旅程中产生影响。

Imperative Care is based in Campbell, Calif. https://imperativecare.com..

Imperative Care总部位于加利福尼亚州坎贝尔。https://imperativecare.com..

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Imperative Care, Inc.

命令式护理公司 （注：通常公司名称会保持原文，这里按照要求翻译为中文）

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Source: businesswire.com

来源：businesswire.com