The Inari Medical FlowTriever device. [Image from Inari Medical]Inari Medical (Nasdaq:NARI) today announced positive results from its prospective PEERLESS trial for the FlowTriever system.

Inari Medical FlowTriever设备。[来自Inari Medical的图片]Inari Medical（纳斯达克股票代码：NARI）今天宣布，其针对FlowTriever系统的预期无与伦比的试验取得了积极成果。

The company designed its FlowTriever for device retrieval and aspiration. The system treats pulmonary embolism (PE). FlowTriever non-surgically removes clots from peripheral blood vessels. Its uses include treatment for PE and clots in transit in the right atrium. It received FDA 510(k) clearance in 2018..

该公司设计了用于设备检索和抽吸的FlowTriever。该系统治疗肺栓塞（PE）。FlowTriever非手术切除外周血管中的凝块。它的用途包括治疗右心房运输中的PE和凝块。2018年获得FDA 510（k）许可。。

Irvine, California-based Inari’s latest study compared FlowTriever to catheter-directed thrombolytics (CDT). Dr. Wissam Jaber, co-principal investigator, presented the results at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C.

位于加利福尼亚州欧文市的Inari的最新研究将FlowTriever与导管导向溶栓药（CDT）进行了比较。联合首席研究员Wissam Jaber博士在华盛顿特区的经导管心血管治疗（TCT）2024上介绍了研究结果。

PEERLESS met its primary composite endpoint, driven by patients experiencing significantly fewer clinical deteriorations or therapy escalations, fewer ICU admissions, and shorter ICU lengths of stay with FlowTriever versus CDT. Patients also registered faster recovery for clinical symptoms and hemodynamics, shorter hospital stays and fewer 30-day readmissions..

PEERLESS达到了其主要复合终点，这是由于患者的临床恶化或治疗升级明显减少，ICU入院人数减少，以及FlowTriever与CDT相比ICU住院时间缩短。患者的临床症状和血流动力学恢复更快，住院时间更短，30天再入院次数更少。。

“These results are crucial to guiding optimal PE treatment decisions, providing strong evidence that FlowTriever may reduce clinical deterioration and the need for reintervention through more effective early thrombus resolution,” said Dr. Jaber. “As the only randomized trial evaluating mechanical thrombectomy in PE, PEERLESS allows us to now confidently say that treatment with FlowTriever is safe, effective, and superior to CDT.”.

Jaber博士说：“这些结果对于指导最佳PE治疗决策至关重要，提供了强有力的证据表明FlowTriever可以通过更有效的早期血栓消退来减少临床恶化和再次干预的需要。”。“作为唯一一项评估PE机械血栓切除术的随机试验，PEERLESS使我们现在可以自信地说，FlowTriever治疗安全，有效，优于CDT。”。

More about the Inari FlowTriever study

关于Inari FlowTriever研究的更多信息

PEERLESS enrolled 550 intermediate-risk PE patients across 57 centers worldwide. It randomized the patients to receive either FlowTriever thrombectomy or CDT. The primary cohort excluded patients with absolute contraindications to thrombolytics and enrolled very few patients with relative contraindications..

PEERLESS在全球57个中心招募了550名中危PE患者。它将患者随机分为接受FlowTriever血栓切除术或CDT。主要队列排除了溶栓绝对禁忌症的患者，并且招募了极少数具有相对禁忌症的患者。。

FlowTriever patients had three times fewer clinical deteriorations and/or therapy escalations to bailout compared to CDT. They also presented greater improvement of clinical symptoms and hemodynamics and 24 hours and fewer 30-day readmissions for faster recovery.

与CDT相比，FlowTriever患者的临床恶化和/或治疗升级次数减少了三倍。他们还表现出临床症状和血流动力学的更大改善，24小时和更少的30天再入院以更快地恢复。

Additionally, Inari said FlowTriever patients had significantly less ICU admissions, ICU length of stay and hospital length of stay. The FlowTriever arm had zero patient deaths at discharge or seven days, zero deteriorations related to cardiac arrest, high-grade AV block, or respiratory failure, and low 0.4% all-cause mortality at 30-day follow-up..

此外，伊纳里说，FlowTriever患者的ICU入院人数，ICU住院时间和住院时间明显减少。FlowTriever组在出院时或七天内患者死亡率为零，与心脏骤停，高度房室传导阻滞或呼吸衰竭相关的恶化为零，在30天的随访中全因死亡率为0.4%。。

“PEERLESS, the first major randomized PE study in over a decade, reiterates our commitment to practice- and guideline-changing research and sets the new standard for clinically meaningful endpoints,” said Dr. Thomas Tu, Inari’s chief medical officer. “The results of this study position FlowTriever as the primary interventional tool for intermediate-risk PE.

Inari首席医学官Thomas Tu博士说：“PEERLESS是十多年来第一项大型随机体育研究，它重申了我们对改变实践和指南的研究的承诺，并为临床上有意义的终点设定了新标准。”。“这项研究的结果将FlowTriever定位为中等风险PE的主要介入工具。

PEERLESS is the first in a series of randomized controlled studies that Inari and others are bringing to light, kicking off the golden age of PE research..

PEERLESS是Inari和其他人揭示的一系列随机对照研究中的第一个，开启了体育研究的黄金时代。。

“I wish to thank our dedicated steering committee and investigators for bringing this trial to reality and contributing to its ongoing impact on patient care.”

“我要感谢我们专门的指导委员会和调查人员将这项试验变为现实，并为其对患者护理的持续影响做出贡献。”